N/A
Completed N=54
Faith-Based Toolbox for African Americans With Dementia
Source: ClinicalTrials.gov NCT04325204 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants Recruited Within the Goal of 12 Months — 14; 14; 13; 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Recruited Within the Goal of 12 Months |
14; 14; 13; 13 | — |
| PRIMARY Number of Participants Engaging in the Intervention at Least Two Days Per Week |
17; 17 | — |
| PRIMARY Number of Dyads Completing the Study |
17; 17 | — |
| PRIMARY Zarit Burden Inventory Score |
36.47; 32.76 | — |
| PRIMARY Perceived Stress Scale Score |
31.94; 30.76 | — |
| PRIMARY Center for Epidemiologic Studies - Depression (CES-D) Scale Score |
— | — |
| PRIMARY Revised Memory and Behavior Problem Checklist Score |
39.00; 38.53 | — |
| PRIMARY Medical Outcomes Study Sleep Scale (MOS-Sleep) Score |
— | — |
| SECONDARY Caregiver Heart Rate Variability Time Domain |
— | — |
| SECONDARY Caregiver Heart Rate Variability Frequency Domain |
— | — |
| SECONDARY Caregiver Skin Conductance Level (SCL) |
— | — |
Eligibility 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 Exclusion Criteria:
- has active plans to move from under care of primary caregiver
- routinely attends church
- hostile to religion
- unwilling to engage in Faith-HAT
Data sourced from ClinicalTrials.gov (NCT04325204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.