Age-related Hearing Impairment 1, Personal Communication
Conditions
Brief summary
Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.
Interventions
BEHAVIORALBaltimore HEARS
Tailored aural rehabilitation for participant and communication partner (if applicable)
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 60 years or older * English-speaking * Aural-oral verbal communication as primary communication modality * Post-lingual hearing loss (Audiometric pure tone averages \[0.5-4kHz\] in both ears \>25 dB) * Does not currently use a hearing amplification device or hearing aid * Signed informed consent to participate in all study related activities * Willing to regularly use listening device once provided for the remainder of their time in the study * Hearing handicap as measured by HHIE-S score \>8 * Able to follow study instructions
Exclusion criteria
* Individuals who do not fulfill inclusion criteria * Evidence of ear disease or pathology requiring further medical evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity. |
| Change From Baseline in Short Form-12 (SF-12) Mental Component Score | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. |
| Change From Baseline in Short Form -12 (SF-12) Physical Component Score | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. |
| Change From Baseline in Cohen Social Network Index (SNI): Network Diversity | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the score from baseline (a positive number) indicates a more diverse network. |
| Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size. |
| Change From Baseline in Valuation of Life | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life. |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. |
| Change From Baseline in Revised UCLA Loneliness Scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | Measure was collected via a one-on-one interview conducted by a trained data collector. Score is the sum of 20-item self-reported measure. Scores range from 20 to 80. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness. |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) | This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) | This measure is a participant's self-reported listening self efficacy on a 0-10 score scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. |
| Change From Baseline in Hearing Knowledge | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) | This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. The score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge. |
| Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | Baseline and 12 months post-intervention | Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap. |
| Change From Baseline in Short Form -12 (SF-12) Mental Component Score | Baseline and 12 months post-intervention | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. |
| Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity | Baseline and 12 months post-intervention | Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the number of roles from baseline (a positive number) indicates a more diverse network. |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) | A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. |
Countries
United States
Participant flow
Recruitment details
Study recruitment began in April 2018 and ended in October 2019. Participants were recruited from independent senior housing in Baltimore City and County and from Baltimore City senior centers and social centers.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Treatment Group Immediate treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | 78 |
| Delayed Treatment Group 3-month delayed treatment with Baltimore HEARS intervention
Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable)
Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | 73 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month Follow-up | Incomplete measurement | 1 | 1 |
| 3 Month Follow-up | Death | 3 | 1 |
| 3 Month Follow-up | Lost to Follow-up | 1 | 1 |
| 3 Month Follow-up | Obtained Hearing Aids | 0 | 1 |
| 3 Month Follow-up | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| 12-Item Short Form Survey (SF-12): Mental Component Score | 48.5 score on a scale STANDARD_DEVIATION 10.1 | 49.4 score on a scale STANDARD_DEVIATION 9.9 | 49 score on a scale STANDARD_DEVIATION 10 |
| 12-Item Short Form Survey (SF-12) Physical Component Score | 39 score on a scale STANDARD_DEVIATION 11 | 39.4 score on a scale STANDARD_DEVIATION 11.1 | 39.2 score on a scale STANDARD_DEVIATION 11 |
| Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Computer Self Efficacy | 19.3 score on a scale STANDARD_DEVIATION 3.9 | 19.1 score on a scale STANDARD_DEVIATION 4.6 | 19.2 score on a scale STANDARD_DEVIATION 4.3 |
| Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | 13.9 units on a scale STANDARD_DEVIATION 1.8 | 14.3 units on a scale STANDARD_DEVIATION 1.8 | 14.1 units on a scale STANDARD_DEVIATION 1.8 |
| Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Self Efficacy | 21.7 units on a scale STANDARD_DEVIATION 2.3 | 20.9 units on a scale STANDARD_DEVIATION 3.1 | 21.3 units on a scale STANDARD_DEVIATION 2.7 |
| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening Self- Efficacy | 7.7 score on a scale STANDARD_DEVIATION 4.9 | 7.3 score on a scale STANDARD_DEVIATION 4.7 | 7.6 score on a scale STANDARD_DEVIATION 4.8 |
| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet Listening Self-Efficacy | 7.4 score on a scale STANDARD_DEVIATION 2.5 | 7.7 score on a scale STANDARD_DEVIATION 2.2 | 7.6 score on a scale STANDARD_DEVIATION 2.4 |
| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening Self-Efficacy | 13.7 score on a scale STANDARD_DEVIATION 4.5 | 13.8 score on a scale STANDARD_DEVIATION 4 | 13.8 score on a scale STANDARD_DEVIATION 4.2 |
| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Total Score | 28.9 score on a scale STANDARD_DEVIATION 10.3 | 28.9 score on a scale STANDARD_DEVIATION 9.1 | 28.9 score on a scale STANDARD_DEVIATION 9.7 |
| Age, Continuous | 76.1 years STANDARD_DEVIATION 7.1 | 78.2 years STANDARD_DEVIATION 8.8 | 77.1 years STANDARD_DEVIATION 8 |
| Cohen Social Network Index (SNI): Network Diversity | 4.8 number of roles STANDARD_DEVIATION 1.9 | 4.9 number of roles STANDARD_DEVIATION 1.7 | 4.8 number of roles STANDARD_DEVIATION 1.8 |
| Cohen Social Network Index (SNI): Social Network Size | 17 number of people | 15.5 number of people | 16 number of people |
| Education High School or Equivalent | 20 Participants | 22 Participants | 42 Participants |
| Education Less than High School | 21 Participants | 21 Participants | 42 Participants |
| Education More than High School | 37 Participants | 30 Participants | 67 Participants |
| Hearing Knowledge | 3.3 score on a scale STANDARD_DEVIATION 1.5 | 3.4 score on a scale STANDARD_DEVIATION 1.7 | 3.4 score on a scale STANDARD_DEVIATION 1.6 |
| Hearing Loss Mild | 43 Participants | 35 Participants | 78 Participants |
| Hearing Loss Moderate to severe | 35 Participants | 38 Participants | 73 Participants |
| HHIE-S (Hearing handicap inventory for the elderly - screening) | 21.7 score on a scale STANDARD_DEVIATION 9.4 | 20.1 score on a scale STANDARD_DEVIATION 10.1 | 21 score on a scale STANDARD_DEVIATION 9.7 |
| Living Arrangement Does not live alone | 25 Participants | 17 Participants | 42 Participants |
| Living Arrangement Lives Alone | 53 Participants | 56 Participants | 109 Participants |
| Monthly Household Income $100,000 to $149,999 | 0 Participants | 1 Participants | 1 Participants |
| Monthly Household Income $25,000 to $49,999 | 16 Participants | 16 Participants | 32 Participants |
| Monthly Household Income $50,000 to $74,999 | 7 Participants | 4 Participants | 11 Participants |
| Monthly Household Income $75,000 to $99,999 | 2 Participants | 2 Participants | 4 Participants |
| Monthly Household Income Don't Know | 3 Participants | 1 Participants | 4 Participants |
| Monthly Household Income Less than $25,000 | 48 Participants | 48 Participants | 96 Participants |
| Monthly Household Income Refused | 2 Participants | 0 Participants | 2 Participants |
| Monthly Household Income Skipped | 0 Participants | 1 Participants | 1 Participants |
| Montreal Cognitive Assessment | 22.6 score on a scale STANDARD_DEVIATION 4.4 | 23.5 score on a scale STANDARD_DEVIATION 3.9 | 23 score on a scale STANDARD_DEVIATION 4.2 |
| Own Smartphone Doesn't own smartphone | 36 Participants | 32 Participants | 68 Participants |
| Own Smartphone NA | 0 Participants | 1 Participants | 1 Participants |
| Own Smartphone Owns smartphone | 42 Participants | 40 Participants | 82 Participants |
| Patient Health Questionnaire - Depression Score (PHQ-9) | 6 score on a scale STANDARD_DEVIATION 4.5 | 5.9 score on a scale STANDARD_DEVIATION 4.5 | 6 score on a scale STANDARD_DEVIATION 4.5 |
| Prior Hearing Aid Use Don't Know | 1 Participants | 0 Participants | 1 Participants |
| Prior Hearing Aid Use No prior Hearing Aid Use | 66 Participants | 52 Participants | 118 Participants |
| Prior Hearing Aid Use Prior Hearing Aid Use | 11 Participants | 21 Participants | 32 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 40 Participants | 25 Participants | 65 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants | 7 Participants | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White Not Hispanic | 37 Participants | 39 Participants | 76 Participants |
| Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) | 6.1 score on a scale STANDARD_DEVIATION 1.7 | 6.1 score on a scale STANDARD_DEVIATION 1.8 | 6.1 score on a scale STANDARD_DEVIATION 1.8 |
| Sex/Gender, Customized Sex Female | 47 Participants | 54 Participants | 101 Participants |
| Sex/Gender, Customized Sex Male | 31 Participants | 17 Participants | 48 Participants |
| Sex/Gender, Customized Sex NA | 0 Participants | 2 Participants | 2 Participants |
| Speech-Frequency Pure Tone Average | 41.5 db HL STANDARD_DEVIATION 12.8 | 42.6 db HL STANDARD_DEVIATION 11.2 | 42 db HL STANDARD_DEVIATION 12 |
| UCLA Loneliness Scale | 23.3 score on a scale STANDARD_DEVIATION 10 | 20.6 score on a scale STANDARD_DEVIATION 9.2 | 22 score on a scale STANDARD_DEVIATION 9.7 |
| Used Computer within past month I do not have or use a computer | 38 Participants | 38 Participants | 76 Participants |
| Used Computer within past month I have or use a computer and I used the internet | 31 Participants | 29 Participants | 60 Participants |
| Used Computer within past month I have or use a computer but I do not go on the internet | 9 Participants | 6 Participants | 15 Participants |
| Used text or email within the past month Most days | 27 Participants | 24 Participants | 51 Participants |
| Used text or email within the past month Not within the past month | 33 Participants | 26 Participants | 59 Participants |
| Used text or email within the past month Rarely | 10 Participants | 10 Participants | 20 Participants |
| Used text or email within the past month Some days | 8 Participants | 13 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 78 | 4 / 73 |
| other Total, other adverse events | 0 / 78 | 0 / 73 |
| serious Total, serious adverse events | 0 / 78 | 0 / 73 |
Outcome results
Primary
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 4 incomplete baseline measures (2 immediate, 2 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~3 incomplete 3 month measures from immediate group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | -13.2 score on a scale | Standard Deviation 10.3 |
| Delayed Treatment Group | Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | .06 score on a scale | Standard Deviation 7.1 |
Secondary
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~12 incomplete 3 month measures (11 immediate, 1 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | -0.5 score on a scale | Standard Deviation 3.8 |
| Delayed Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | 0 score on a scale | Standard Deviation 3.2 |
Secondary
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 12 months post-intervention
Population: 0 incomplete baseline (0 immediate, 0 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~28 incomplete 12 month measures (14 immediate, 14 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | 0.3 score on a scale | Standard Deviation 3.9 |
| Delayed Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | 0.2 score on a scale | Standard Deviation 2.9 |
Secondary
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 3 incomplete baseline measures (1 immediate, 2 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~10 incomplete 3 month measures from immediate group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | -0.6 score on a scale | Standard Deviation 3.8 |
| Delayed Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | -0.1 score on a scale | Standard Deviation 3.6 |
Secondary
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 12 months post-intervention
Population: 3 incomplete at baseline (1 immediate, 2 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~28 incomplete 12 month measures (14 immediate, 14 delay)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | -0.6 score on a scale | Standard Deviation 3.5 |
| Delayed Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | -0.4 score on a scale | Standard Deviation 3 |
Secondary
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 12 months post-intervention
Population: 0 incomplete at baseline (0)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~28 incomplete 12 month measures (14 immediate, 14 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | 0.9 score on a scale | Standard Deviation 2.2 |
| Delayed Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | 0.1 score on a scale | Standard Deviation 2 |
Secondary
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~10 incomplete 3 month measures in immediate group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | 0.7 score on a scale | Standard Deviation 2.3 |
| Delayed Treatment Group | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | -0.4 score on a scale | Standard Deviation 2.5 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 12 months post-intervention
Population: 1 incomplete at baseline (0 immediate, 1 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~28 incomplete 12 month measures (14 immediate, 14 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | 4.0 score on a scale | Standard Deviation 5.6 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | 4.8 score on a scale | Standard Deviation 5.3 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Population: 1 incomplete baseline measures (1 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~12 incomplete 3 month measures (12 immediate)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | 5.1 score on a scale | Standard Deviation 5.7 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | -0.1 score on a scale | Standard Deviation 4.3 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
This measure is a participant's self-reported listening self efficacy on a 0-10 score scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Population: 1 incomplete baseline measures (1 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~12 incomplete 3 month measures (12 immediate)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | 1.5 score on a scale | Standard Deviation 2.7 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | -0.6 score on a scale | Standard Deviation 2.8 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
This measure is a participant's self-reported listening self efficacy on a 0-10 scale in a directed listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 12 months post-intervention
Population: 1 incomplete at baseline (0 immediate, 1 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~29 incomplete 12 month measures (14 immediate, 15 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | 1.5 score on a scale | Standard Deviation 1.9 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | 0.8 score on a scale | Standard Deviation 2.8 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in directed listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 12 months post-intervention
Population: 2 incomplete baseline measure (0 immediate, 2 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~28 incomplete 12 month measures (14 immediate, 14 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | 2.8 score on a scale | Standard Deviation 3.8 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | 2.5 score on a scale | Standard Deviation 4.5 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Population: 2 incomplete baseline measures (2 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~12 incomplete 3 month measures (12 immediate)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | 4.2 score on a scale | Standard Deviation 5.1 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | -0.1 score on a scale | Standard Deviation 4.5 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 12 months post-intervention
Population: 2 incomplete at baseline (0 immediate, 2 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~28 incomplete 12 month measures (14 immediate, 14 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | 8.3 score on a scale | Standard Deviation 9.3 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | 8.2 score on a scale | Standard Deviation 10.7 |
Secondary
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Population: 2 incomplete baseline measures (2 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~12 incomplete 3 month measures (12 immediate)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | 10.8 score on a scale | Standard Deviation 11.3 |
| Delayed Treatment Group | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | -0.7 score on a scale | Standard Deviation 8.1 |
Secondary
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the number of roles from baseline (a positive number) indicates a more diverse network.
Time frame: Baseline and 12 months post-intervention
Population: 5 incomplete at baseline (3 immediate, 2 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~27 incomplete 12 month measures (15 immediate, 12 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity | -0.1 contact roles | Standard Deviation 1 |
| Delayed Treatment Group | Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity | -0.2 contact roles | Standard Deviation 1.3 |
Secondary
Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the score from baseline (a positive number) indicates a more diverse network.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 5 incomplete measures at baseline (3 immediate, 2 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~17 incomplete 3 month measures (12 immediate, 5 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Cohen Social Network Index (SNI): Network Diversity | 0.3 number of roles | Standard Deviation 1.2 |
| Delayed Treatment Group | Change From Baseline in Cohen Social Network Index (SNI): Network Diversity | -0.0 number of roles | Standard Deviation 1.2 |
Secondary
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 5 incomplete baseline measures (3 immediate, 2 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~17 incomplete 3 month measures (12 immediate, 5 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | 1.8 number of individuals | Standard Deviation 10.5 |
| Delayed Treatment Group | Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | 1.0 number of individuals | Standard Deviation 7.2 |
Secondary
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size.
Time frame: Baseline and 12 months post-intervention
Population: 5 incomplete at baseline (3 immediate, 2 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~27 incomplete at 12 month (15 immediate, 12 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | -1.5 individuals | Standard Deviation 12.4 |
| Delayed Treatment Group | Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | -3.7 individuals | Standard Deviation 10.4 |
Secondary
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Time frame: Baseline and 12 months post-intervention
Population: 4 incomplete baseline measure (2 immediate, 2 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~8 incomplete 12 month measures (6 immediate, 3 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | -10.3 score on a scale | Standard Deviation 11 |
| Delayed Treatment Group | Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | -8.2 score on a scale | Standard Deviation 13.4 |
Secondary
Change From Baseline in Hearing Knowledge
This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. Score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.
Time frame: Baseline and 12 months post-intervention
Population: 9 incomplete at baseline (5 immediate, 4 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~27 incomplete 12 month measures (12 immediate, 15 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Hearing Knowledge | 0.2 score on a scale | Standard Deviation 1.7 |
| Delayed Treatment Group | Change From Baseline in Hearing Knowledge | 0.0 score on a scale | Standard Deviation 1.7 |
Secondary
Change From Baseline in Hearing Knowledge
This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. The score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.
Time frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Population: 9 incomplete baseline measures (5 immediate, 4 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~14 incomplete 3 month measures (12 immediate, 2 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Hearing Knowledge | 0.2 score on a scale | Standard Deviation 1.6 |
| Delayed Treatment Group | Change From Baseline in Hearing Knowledge | -0.4 score on a scale | Standard Deviation 1.5 |
Secondary
Change From Baseline in Revised UCLA Loneliness Scale
Measure was collected via a one-on-one interview conducted by a trained data collector. Score is the sum of 20-item self-reported measure. Scores range from 20 to 80. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness.
Time frame: Baseline and 12 months post-intervention
Population: 5 incomplete baseline measure (3 immediate, 2 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~30 incomplete 12 month measures (19 immediate, 11 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Revised UCLA Loneliness Scale | -1.3 score on a scale | Standard Deviation 6.8 |
| Delayed Treatment Group | Change From Baseline in Revised UCLA Loneliness Scale | -1.9 score on a scale | Standard Deviation 9 |
Secondary
Change From Baseline in Revised UCLA Loneliness Scale
Measure was collected via a one-on-one interview conducted by a trained data collector. Score is the sum of 20-item self-reported measure. Scores range from 20 to 80. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 5 incomplete baseline measures (3 immediate, 2 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~16 incomplete 3 month measures (11 immediate, 5 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Revised UCLA Loneliness Scale | -2.8 score on a scale | Standard Deviation 8.7 |
| Delayed Treatment Group | Change From Baseline in Revised UCLA Loneliness Scale | -0.6 score on a scale | Standard Deviation 7 |
Secondary
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 8 incomplete baseline measures (3 immediate, 5 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~11 incomplete 3 month measures (9 immediate, 2 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | -1 score on a scale | Standard Deviation 4.3 |
| Delayed Treatment Group | Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | -0.2 score on a scale | Standard Deviation 4 |
Secondary
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity.
Time frame: Baseline and 12 months post-intervention
Population: 8 missing at baseline (3 immediate, 5 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~22 Incomplete 12 month measures (8 immediate, 14 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | -0.3 score on a scale | Standard Deviation 3.3 |
| Delayed Treatment Group | Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | -1.1 score on a scale | Standard Deviation 4.5 |
Secondary
Change From Baseline in Short Form -12 (SF-12) Mental Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Time frame: Baseline and 12 months post-intervention
Population: 6 incomplete at baseline (3 immediate, 3 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~27 incomplete 12 month measures (12 immediate, 15 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Short Form -12 (SF-12) Mental Component Score | 0.5 score on a scale | Standard Deviation 9.9 |
| Delayed Treatment Group | Change From Baseline in Short Form -12 (SF-12) Mental Component Score | 0.7 score on a scale | Standard Deviation 13 |
Secondary
Change From Baseline in Short Form-12 (SF-12) Mental Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 6 incomplete baseline measures (3 immediate, 3 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~12 incomplete 3 month measures (11 immediate, 1 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Short Form-12 (SF-12) Mental Component Score | 1.1 score on a scale | Standard Deviation 11.2 |
| Delayed Treatment Group | Change From Baseline in Short Form-12 (SF-12) Mental Component Score | -1.4 score on a scale | Standard Deviation 10 |
Secondary
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Time frame: Baseline and 12 months post-intervention
Population: 6 incomplete at baseline (3 immediate, 3 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~27 incomplete 12 month measures (12 immediate, 15 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Short Form -12 (SF-12) Physical Component Score | 1.0 score on a scale | Standard Deviation 9.3 |
| Delayed Treatment Group | Change From Baseline in Short Form -12 (SF-12) Physical Component Score | 1.7 score on a scale | Standard Deviation 11.4 |
Secondary
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 6 incomplete baseline measures (3 immediate, 3 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~12 incomplete 3 month measures (11 immediate, 1 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Short Form -12 (SF-12) Physical Component Score | 4.4 score on a scale | Standard Deviation 10.4 |
| Delayed Treatment Group | Change From Baseline in Short Form -12 (SF-12) Physical Component Score | -0.4 score on a scale | Standard Deviation 10.1 |
Secondary
Change From Baseline in Valuation of Life
This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life.
Time frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Population: 7 incomplete baseline measures (3 immediate, 4 delayed)~1 obtained hearing aids (1 delayed)~1 withdrew consent (1 immediate)~4 non-study related deaths (3 immediate, 1 delayed)~2 lost to follow up (1 immediate, 1 delayed)~11 incomplete 3 month measures (10 immediate, 1 delayed)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Valuation of Life | 0.1 score on a scale | Standard Deviation 6.9 |
| Delayed Treatment Group | Change From Baseline in Valuation of Life | -0.6 score on a scale | Standard Deviation 5.1 |
Secondary
Change From Baseline in Valuation of Life
This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life.
Time frame: Baseline and 12 months post-intervention
Population: 7 incomplete baseline (3 immediate, 4 delayed)~14 withdrew consent (4 immediate, 10 delayed)~6 non-study related deaths (3 immediate, 3 delayed)~13 lost to follow up (8 immediate, 5 delayed)~25 incomplete 12 month measures (14 immediate, 11 delay)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Change From Baseline in Valuation of Life | -1.9 score on a scale | Standard Deviation 6.6 |
| Delayed Treatment Group | Change From Baseline in Valuation of Life | -1.0 score on a scale | Standard Deviation 7.6 |