SUPPORT-D Intervention for Persons With Alzheimer's Disease and Their Caregivers.
Study Details
Study Description
Brief Summary
The purpose of this research is pilot test a nurse led intervention previously used in patients with pulmonary fibrosis and their caregivers in a new population (persons living with Alzheimer's disease and their caregivers. The researchers hypothesize improving advanced care planning in this population will result in enhanced quality of life over illness trajectory and improve safety for community dwelling PWD/CG dyads. Findings from this study will inform additional necessary adaptations required prior to conducting larger scale powered randomized control trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SUPPORT-D Group
|
Behavioral: A Program of SUPPORT-D (dementia)
The SUPPORT-D intervention consists educational materials will be presented in a format with enhanced content (face-to-face virtually delivered by nurse interventionist via telehealth (e.g., MS Teams), with printed booklet, and identical digital content (electronic pdf and recorded videos of printed content). The SUPPORT-D intervention will be addressed in four sequential sections including: 1) understanding the disease 2) caring for myself; 3) information for the caregiver; and 4) planning for the future. Within the four sections of the intervention seven topics are addressed included symptom management, understanding your disease, putting safety first, ongoing conversations, respite care, palliative care, and alternative treatments. Participants will attend a total of 4 study visits across 8 weeks (approximately every 2 weeks).
|
Outcome Measures
Primary Outcome Measures
- Change in Alzheimer's Disease Knowledge Scale (ADKS) score [baseline, at study completion, an average of 8 weeks]
30 items (T/F) summed total of correct items higher score indicates higher knowledge
- Acceptability of Intervention Measure (AIM) score [at study completion, an average of 8 weeks]
4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention
- Change in feasibility score [at study completion, an average of 8 weeks]
4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention
- Change Zarit caregiver burden score [baseline, at study completion, an average of 8 weeks]
12 items (4 point Likert scale) summed score with higher scores indicating greater caregiver distress
- Change in Perceived Stress scale score [baseline and at study completion, an average of 8 weeks]
10 items (4 point Likert scale) summed score across items with higher scores indicate greater levels of stress
- Change in Symptom burden physical function score [baseline and at study completion, an average of 8 weeks]
4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased physical function
- Change in Symptom burden anxiety score [baseline and at study completion, an average of 8 weeks]
4 item scale (4 point Likert scale) Standard t scores with higher scores indicating increased anxiety
- Change in Symptom burden depression score [baseline and at study completion, an average of 8 weeks]
4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased depression
- Change in Symptom burden fatigue score [baseline and at study completion, an average of 8 weeks]
4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased fatigue
- Change in Symptom burden sleep quality score [baseline and at study completion, an average of 8 weeks]
4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased sleep quality
- Change in Symptom burden satisfaction with social role score [baseline and at study completion, an average of 8 weeks]
4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased satisfaction with social role
- Change in Symptom burden pain score [baseline and at study completion, an average of 8 weeks]
4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased pain
- Change in Quality of life-Alzheimer's Disease (QoL-AD) score [baseline and at study completion, an average of 8 weeks]
13 items (4 point Likert scale) summed score across items with higher scores indicating better quality of life.
- Change in self-efficacy for caregiving score [baseline and at study completion, an average of 8 weeks]
8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy
- Change in Safety assessment scale score [baseline and at study completion, an average of 8 weeks]
32 items summed score across items with higher scores indicating higher risk for accidents
- Change in technology literacy score [baseline and at study completion, an average of 8 weeks]
21 items (4 point Likert scale) summed scores across items with higher scores indicating better digital health literacy
- Number of participants completing advance care planning documents [at study completion, an average of 8 weeks]
Number of participants who complete advance care planning documents
- Appropriateness of Intervention score [at study completion, an average of 8 weeks]
4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
The participants in this study include persons with Alzheimer's disease (PWD) and their caregivers (CG.
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Persons with Alzheimer's Disease (we anticipate cognitive impairment within this group)
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18 years old or older
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Diagnosis of Alzheimer's Disease or suspected Alzheimer's disease within prior 12 months (FAST score < 3)
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Able to read and speak English (intervention in English)
Caregivers (CG)
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18 years old
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Non-paid (eliminates professional caregivers)
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Provides care to someone living with Alzheimer's Disease or suspected Alzheimer's disease (self-report)
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Able to read and speak English (written materials in English)
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No diagnosis of cognitive impairment
Exclusion Criteria:
- Inability or unwillingness to provide informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical University of South Carolina
- National Center for Advancing Translational Science (NCATS)
Investigators
- Principal Investigator: Diana M Layne, PhD, Medical University of South Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00120938
- KL2TR001452
- UL1TR001450