SUPPORT-D Intervention for Persons With Alzheimer's Disease and Their Caregivers

Study Overview
=================
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 Mild Cognitive Impairment or 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.

Official Title
-----------------
Palliative Care Telehealth Delivered Program of SUPPORT-D Intervention for Persons With Alzheimer's Disease and Caregivers Phase 2

Conditions
-----------------
Alzheimer Disease, Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: A Program of SUPPORT-D (dementia)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participants in this study include persons with Alzheimer's disease (PWD) and their caregivers (CG. Persons with Alzheimer's Disease (investigators anticipate cognitive impairment within this group) 18 years old or older Diagnosis of Alzheimer's Disease or suspected Alzheimer's disease (FAST score < 4) Able to read and speak English (intervention in English) Caregivers (CG) > 18 years old Non-paid (eliminates professional caregivers) Provides care to someone living with Alzheimer's Disease or suspected Alzheimer's disease (self-report) Able to read and speak English (written materials in English) No diagnosis of cognitive impairment Exclusion Criteria: Inability or unwillingness to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUPPORT-D Group<br> | Behavioral: A Program of SUPPORT-D (dementia)<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alzheimer's Disease Knowledge Scale (ADKS) score | 30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30) | baseline, at study completion, an average of 8 weeks | 
| Acceptability of Intervention Measure (AIM) score | 4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20) | at study completion, an average of 8 weeks | 
| Change in feasibility score | 4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20) | at study completion, an average of 8 weeks | 
| Change Zarit caregiver burden score | 12 items (4 point Likert scale) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48) | baseline, at study completion, an average of 8 weeks | 
| Change in Perceived Stress scale score | 10 items (4 point Likert scale) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40) | baseline and at study completion, an average of 8 weeks | 
| Change in Symptom burden physical function score | 4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased physical function (raw scores range from 4-20) | baseline and at study completion, an average of 8 weeks | 
| Change in Symptom burden anxiety score | 4 item scale (4 point Likert scale) Standard t scores with higher scores indicating increased anxiety (raw scores range from 4-20) | baseline and at study completion, an average of 8 weeks | 
| Change in Symptom burden depression score | 4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased depression (raw scores range from 4-20) | baseline and at study completion, an average of 8 weeks | 
| Change in Symptom burden fatigue score | 4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased fatigue (raw scores range from 4-20) | baseline and at study completion, an average of 8 weeks | 
| Change in Symptom burden sleep quality score | 4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased sleep quality (raw scores range from 4-20) | baseline and at study completion, an average of 8 weeks | 
| Change in Symptom burden satisfaction with social role score | 4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased satisfaction with social role (raw scores range from 4-20) | baseline and at study completion, an average of 8 weeks | 
| Change in Symptom burden pain score | 4 item scale (5 point Likert scale) Standard t scores with higher scores indicating increased pain (raw scores range from 4-20) | baseline and at study completion, an average of 8 weeks | 
| Change in Quality of life-Alzheimer's Disease (QoL-AD) score | 13 items (4 point Likert scale) summed score across items with higher scores indicating better quality of life (scores range from 13-54) | baseline and at study completion, an average of 8 weeks | 
| Change in self-efficacy for caregiving score | 8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80) | baseline and at study completion, an average of 8 weeks | 
| Change in Safety assessment scale score | 32 items summed score across items with higher scores indicating higher risk for accidents (scores range from 11-47) | baseline and at study completion, an average of 8 weeks | 
| Change in technology literacy score | 21 items (4 point Likert scale) summed scores across items with higher scores indicating better digital health literacy (scores range from 21-84) | baseline and at study completion, an average of 8 weeks | 
| Number of participants completing advance care planning documents | Number of participants who complete advance care planning documents | at study completion, an average of 8 weeks | 
| Appropriateness of Intervention score | 4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20) | at study completion, an average of 8 weeks |