Alzheimer Disease, Dementia
Conditions
Keywords
Religion, Spirituality
Brief summary
The purpose of this study is to create and test faith-based activities that might be useful for African American adults with moderate and severe dementia and their caregivers. The study aims to enroll 30 dyads of people with moderate and severe dementia and their family caregivers.
Detailed description
African Americans (AAs) are more likely than other racial/ethnic groups to be diagnosed with Alzheimer's disease and related dementias (ADRD) and will account for 20% of persons living with dementia (PLWD) by 2050. PLWD experience progressive distress and confusion, which decreases their quality of life and also contributes to the emotional strain, burden, social isolation, and depression experienced by caregivers. Research indicates that religiosity (the inner commitment to one's faith through integration of religious beliefs and practices into one's life) can serve as a protective factor against the stressors associated with caregiving and living with ADRD. The goal of this clinical feasibility trial and NIH stage 1 intervention development project is to go beyond the four walls of the church to find ways to meet the spiritual needs of persons living with moderate and severe ADRD where they are in order to help them remain religiously and spiritually engaged. This study is premised on the notion that religious/spiritual engagement is possible and beneficial for PLWD and that this beneficial effect will extend to their caregivers. The purpose of this project is to design and test the feasibility of employing components of a Faith-based Home Activity Toolbox (Faith-HAT) and create intervention tools for a full-scale randomized controlled trial (RCT) to test the efficacy-effectiveness of faith-based programs on patient and caregiver outcomes. Thirty dyads of people with dementia and their caregivers will be enrolled in a 6 week program to test the feasibility and preliminary effectiveness of using Faith-HAT. A final study follow-up assessment occurs 6 weeks after the end of the intervention.
Interventions
BEHAVIORALFaith-based Home Activity Toolbox (Faith-HAT)
They will select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons. Faith-HAT will be placed on online, which requires little technical know-how by users. The PI will provide training to participants on how to use the Faith-HAT and online diary on the tablet computer provided by the project.
Sponsors
National Institute on Aging (NIA)
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Caregiver Inclusion Criteria: * at least 18 years of age * reside with and care for (average of 4 hours/per day of unpaid assistance) for a family or friend experiencing signs and symptoms of moderate or severe ADRD as indicated through self-report or family caregiver report * able to read, speak, and understand English * cognitively intact * access to a wireless internet connection (wi-fi) * access to a phone or mobile device that accepts text messages PLWD Inclusion Criteria: * community-dwelling experiencing signs and symptoms of moderate or severe ADRD through self-report or family caregiver report * has a family caregiver that resides with them and is willing to participate * no plan for institutionalization in the next month * history of participating in private or public religious activities * understands English (toolbox activities will be produced in English) * family and self-reporting of the level of cognitive impairment identified according to the signs and symptoms of moderate and severe ADRD associated with the Alzheimer's Association16 categorization of moderate/middle, and severe/late stages of dementia Caregiver
Exclusion criteria
* does not have a history of participating in private or public religious activities * hostile to PLWD religious expression * has active plans to move to another residence without family member with ADRD PLWD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcomes Study Sleep Scale (MOS-Sleep) Score | Baseline, Week 6 | The Medical Outcomes Study Sleep Scale (MOS-Sleep) measures sleep quality in the past four weeks. The MOS-Sleep includes 12 items assessing the dimensions of sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Nine of the 12 items are used to create a sleep problem index. Scores for each of the dimensions and the sleep problem index are converted to a 0 to 100 scale, where higher scores indicate more of the dimension attribute or increased problems with sleep (for the sleep problem index). |
| Perceived Stress Scale Score | Baseline, Week 6 | Caregiver stress was assessed with the 14-item Perceived Stress Scale. Responses are given on a scale of 0 to 4 where 0 = never and 4 = very often. Total scores range from 0 to 56 with higher scores indicating greater perceived stress by caregivers. |
| Center for Epidemiologic Studies - Depression (CES-D) Scale Score | Baseline, Week 6 | Caregiver depression will be assessed with the 20-item Center for Epidemiologic Studies - Depression Scale. Caregivers are asked how frequently they have experienced specific symptoms of depression in the past week. Responses are given as 0 = rarely, 1 = 1-2 days, 2 = 3-4 days, and 4 = 5-7 days. Total scores range from 0 to 80 with higher scores indicating greater symptoms of depression. |
| Revised Memory and Behavior Problem Checklist Score | Baseline, Week 6 | The Revised Memory and Behavior Problem Checklist assesses the presence of problematic behaviors in persons with dementia as well as caregiver distress due to those problems. Caregivers complete the 24-item instrument by indicating whether or not the behavior has occurred and how distressing the behaviors are for them on a scale from 0 to 4 (where 0 = not at all and 4 = extremely). Total scores assessing caregiver reactions to problem behaviors range from 0 to 96 with higher scores indicating greater difficulty with problem behaviors. |
| Number of Participants Recruited Within the Goal of 12 Months | At enrollment (up to 21 months of study) | Feasibility of the intervention is assessed by how many months it takes to recruit all study participants. The researchers aimed to complete recruitment within 12 months, enrolling 2 to 3 dyads per month. |
| Number of Participants Engaging in the Intervention at Least Two Days Per Week | Week 6 | Engagement with the intervention is assessed by the number of participants who reported engaging with Faith-HAT at least two days per week during the 6 week intervention. |
| Number of Dyads Completing the Study | Month 20 of the study | The feasibility of the intervention is assessed by study retention, specifically, the number of dyads completing the study. |
| Zarit Burden Inventory Score | Baseline, Week 6 | The amount of burden felt by caregivers was assessed with the 22-item Zarit Burden Inventory. Responses are given on a scale from 0 to 4 where for 0 = never and 4 = nearly always. Total scores range from 0 to 88, where higher scores indicate greater feelings of caregiver burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Heart Rate Variability Time Domain | Baseline, Week 6 | Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the time domain of heart rate variability. Mean peak-to-peak intervals will be assessed in seconds. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention. |
| Caregiver Skin Conductance Level (SCL) | Baseline, Week 6 | Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of skin conductance level. Skin conductance level is the electrical conductivity of the skin. Skin conducts electricity better during physiological or psychological arousal, making skin conductance level a maker for measuring emotion. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention. |
| Caregiver Heart Rate Variability Frequency Domain | Baseline, Week 6 | Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the frequency domain, measured in Hertz (Hz), of heart rate variability. Parasympathetic control is characterized as high frequency (0.15-0.40 Hz) while low frequency (0.04-0.15 Hz) characterizes both the sympathetic and parasympathetic activities. Exposure of an individual to a physical or mental stressor activates their stress response through the sympathetic nervous system (SNS) axis. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention. |
Countries
United States
Participant flow
Recruitment details
Participants are dyads of community members in the metropolitan area of Atlanta, Georgia, USA. Participant enrollment began August 19, 2021 and follow-up assessments were completed by July 13, 2023.
Participants by arm
| Arm | Count |
|---|---|
| Caregivers Caregivers of a person living with dementia participating in the Faith-based Home Activity Toolbox (Faith-HAT) intervention for 6 weeks. | 27 |
| Persons Living With Dementia Persons living with dementia participating in the Faith-HAT intervention for 6 weeks. | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Completed the demographic questionnaire but lost to follow-up before beginning the intervention | 1 | 1 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Death of dyad partner, after the intervention and prior to the assessment 6 weeks post-intervention | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 8 |
Baseline characteristics
| Characteristic | Caregivers | Total | Persons Living With Dementia |
|---|---|---|---|
| Age, Continuous | 58.30 years STANDARD_DEVIATION 10.11 | 68.85 years STANDARD_DEVIATION 13.98 | 79.41 years STANDARD_DEVIATION 7.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 54 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 54 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 Participants | 54 Participants | 27 Participants |
| Sex: Female, Male Female | 26 Participants | 45 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 1 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Center for Epidemiologic Studies - Depression (CES-D) Scale Score
Caregiver depression will be assessed with the 20-item Center for Epidemiologic Studies - Depression Scale. Caregivers are asked how frequently they have experienced specific symptoms of depression in the past week. Responses are given as 0 = rarely, 1 = 1-2 days, 2 = 3-4 days, and 4 = 5-7 days. Total scores range from 0 to 80 with higher scores indicating greater symptoms of depression.
Time frame: Baseline, Week 6
Population: To decrease the number of surveys administered, reactions to problematic behaviors was used as a marker for depression and was assessed with the Revised Memory and Behavior Problem Checklist. The CES-D instrument was not administered to any participants.
Primary
Medical Outcomes Study Sleep Scale (MOS-Sleep) Score
The Medical Outcomes Study Sleep Scale (MOS-Sleep) measures sleep quality in the past four weeks. The MOS-Sleep includes 12 items assessing the dimensions of sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Nine of the 12 items are used to create a sleep problem index. Scores for each of the dimensions and the sleep problem index are converted to a 0 to 100 scale, where higher scores indicate more of the dimension attribute or increased problems with sleep (for the sleep problem index).
Time frame: Baseline, Week 6
Population: The online form used for this survey did not record responses accurately and the information that was collected was not usable.
Primary
Number of Dyads Completing the Study
The feasibility of the intervention is assessed by study retention, specifically, the number of dyads completing the study.
Time frame: Month 20 of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caregivers | Number of Dyads Completing the Study | 17 Participants |
| Persons Living With Dementia | Number of Dyads Completing the Study | 17 Participants |
Primary
Number of Participants Engaging in the Intervention at Least Two Days Per Week
Engagement with the intervention is assessed by the number of participants who reported engaging with Faith-HAT at least two days per week during the 6 week intervention.
Time frame: Week 6
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caregivers | Number of Participants Engaging in the Intervention at Least Two Days Per Week | 17 Participants |
| Persons Living With Dementia | Number of Participants Engaging in the Intervention at Least Two Days Per Week | 17 Participants |
Primary
Number of Participants Recruited Within the Goal of 12 Months
Feasibility of the intervention is assessed by how many months it takes to recruit all study participants. The researchers aimed to complete recruitment within 12 months, enrolling 2 to 3 dyads per month.
Time frame: At enrollment (up to 21 months of study)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Caregivers | Number of Participants Recruited Within the Goal of 12 Months | Enrolled during first 12 months of the study | 14 Participants |
| Caregivers | Number of Participants Recruited Within the Goal of 12 Months | Enrolled after the first 12 months of the study | 13 Participants |
| Persons Living With Dementia | Number of Participants Recruited Within the Goal of 12 Months | Enrolled during first 12 months of the study | 14 Participants |
| Persons Living With Dementia | Number of Participants Recruited Within the Goal of 12 Months | Enrolled after the first 12 months of the study | 13 Participants |
Primary
Perceived Stress Scale Score
Caregiver stress was assessed with the 14-item Perceived Stress Scale. Responses are given on a scale of 0 to 4 where 0 = never and 4 = very often. Total scores range from 0 to 56 with higher scores indicating greater perceived stress by caregivers.
Time frame: Baseline, Week 6
Population: This analysis includes caregiver participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregivers | Perceived Stress Scale Score | Baseline | 31.94 score on a scale | Standard Deviation 4.56 |
| Caregivers | Perceived Stress Scale Score | Week 6 | 30.76 score on a scale | Standard Deviation 5.17 |
Primary
Revised Memory and Behavior Problem Checklist Score
The Revised Memory and Behavior Problem Checklist assesses the presence of problematic behaviors in persons with dementia as well as caregiver distress due to those problems. Caregivers complete the 24-item instrument by indicating whether or not the behavior has occurred and how distressing the behaviors are for them on a scale from 0 to 4 (where 0 = not at all and 4 = extremely). Total scores assessing caregiver reactions to problem behaviors range from 0 to 96 with higher scores indicating greater difficulty with problem behaviors.
Time frame: Baseline, Week 6
Population: This analysis includes caregiver participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregivers | Revised Memory and Behavior Problem Checklist Score | Baseline | 39.00 score on a scale | Standard Deviation 24.35 |
| Caregivers | Revised Memory and Behavior Problem Checklist Score | Week 6 | 38.53 score on a scale | Standard Deviation 24.47 |
Primary
Zarit Burden Inventory Score
The amount of burden felt by caregivers was assessed with the 22-item Zarit Burden Inventory. Responses are given on a scale from 0 to 4 where for 0 = never and 4 = nearly always. Total scores range from 0 to 88, where higher scores indicate greater feelings of caregiver burden.
Time frame: Baseline, Week 6
Population: This analysis includes caregiver participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caregivers | Zarit Burden Inventory Score | Baseline | 36.47 score on a scale | Standard Deviation 13.28 |
| Caregivers | Zarit Burden Inventory Score | Week 6 | 32.76 score on a scale | Standard Deviation 14.09 |
Secondary
Caregiver Heart Rate Variability Frequency Domain
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the frequency domain, measured in Hertz (Hz), of heart rate variability. Parasympathetic control is characterized as high frequency (0.15-0.40 Hz) while low frequency (0.04-0.15 Hz) characterizes both the sympathetic and parasympathetic activities. Exposure of an individual to a physical or mental stressor activates their stress response through the sympathetic nervous system (SNS) axis. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Time frame: Baseline, Week 6
Population: None of the caregiver participants wore the wristband sensor for 24 hours, thus there were not adequate data for any participant to perform valid calculations of longer-duration heart rate variability. Caregivers reported that wearing the wristband sensor was burdensome and stressful and after the first 5 caregiver participants had unsuccessful attempts for the baseline assessment the investigators discontinued use of the wearable sensor in this study.
Secondary
Caregiver Heart Rate Variability Time Domain
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the time domain of heart rate variability. Mean peak-to-peak intervals will be assessed in seconds. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Time frame: Baseline, Week 6
Population: None of the caregiver participants wore the wristband sensor for 24 hours, thus there were not adequate data for any participant to perform valid calculations of longer-duration heart rate variability. Caregivers reported that wearing the wristband sensor was burdensome and stressful and after the first 5 caregiver participants had unsuccessful attempts for the baseline assessment the investigators discontinued use of the wearable sensor in this study.
Secondary
Caregiver Skin Conductance Level (SCL)
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of skin conductance level. Skin conductance level is the electrical conductivity of the skin. Skin conducts electricity better during physiological or psychological arousal, making skin conductance level a maker for measuring emotion. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Time frame: Baseline, Week 6
Population: None of the caregiver participants wore the wristband sensor for 24 hours, thus there were not adequate data for any participant to perform valid calculations of longer-duration measurement of skin conductance level. Caregivers reported that wearing the wristband sensor was burdensome and stressful and after the first 5 caregiver participants had unsuccessful attempts for the baseline assessment the investigators discontinued use of the wearable sensor in this study.