Blindness, Deafness
Conditions
Keywords
deafness-blindness, pilot study, self management education, dual sensory loss, rehabilitation, peer support groups, age related
Brief summary
This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.
Detailed description
This pilot study will enrolled 13 Veterans with Dual Sensory Loss (DSL), age 65 to over 89. The project headquarters in the Portland Oregon Veterans Affairs Medical Center will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators enrolled the 13 Veterans. Staff turnover reduced time available for enrollment and data collection. We therefore eliminated the original comparison group design and this study had only one experimental intervention arm and no control intervention or other arm. Veterans were chronologically enrolled who responded to recruitment letters and who passed telephone and onsite screening. The intervention consisted of six weekly two hour workshops providing information, skills training and exercises about self-managing DSL effects on daily life. Preliminary effectiveness data was collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach. This study data tracked pre and post intervention within subject changes.
Interventions
BEHAVIORALDSL Workshop
A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.
Sponsors
Atlanta VA Medical Center
US Department of Veterans Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veteran; * Vision loss \> 20/70 better eye; * Hearing loss \> 40 decibels better ear; * Cognition Within Normal Limits (WNL); * No behavioral flag or psychiatric diagnosis; * Documented psychosocial restrictions secondary to vision and hearing loss
Exclusion criteria
* Vision and/or hearing can be corrected by surgical or pharmacological treatment; * Requires use of sign language interpreter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Profile of Mood States Total Score. | Change in Profile of Mood States Score from Baseline to 8 Weeks | The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSL Workshop Participants Three to five Veterans with DSL.
DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | DSL Workshop Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 85 years STANDARD_DEVIATION 7.9 |
| Profiles of Mood States Total Score | 16 units on a scale STANDARD_DEVIATION 26.2 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
Change in Profile of Mood States Total Score.
The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.
Time frame: Change in Profile of Mood States Score from Baseline to 8 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSL Workshop Participants | Change in Profile of Mood States Total Score. | 4.5 units on a scale | Standard Deviation 21.9 |