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

March 21, 2025 updated by: Diana Layne, Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alzheimer's Disease Knowledge Scale (ADKS) Score
Time Frame: baseline, at study completion, an average of 8 weeks
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
Time Frame: 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 (raw score ranges from 4-20)
at study completion, an average of 8 weeks
Feasibility Score
Time Frame: 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 (raw scores range from 4-20)
at study completion, an average of 8 weeks
Change Zarit Caregiver Burden Score
Time Frame: baseline, at study completion, an average of 8 weeks
12 items (5 point Likert scale (0-4)) 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
Time Frame: baseline and at study completion, an average of 8 weeks
10 items (4 point Likert scale ranging from 0-4) 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 Quality of Life-Alzheimer's Disease (QoL-AD) Score
Time Frame: baseline and at study completion, an average of 8 weeks
13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52)
baseline and at study completion, an average of 8 weeks
Change in Self-efficacy for Caregiving Score
Time Frame: 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 (raw scores range from 8-80)
baseline and at study completion, an average of 8 weeks
Change in Safety Assessment Scale Score
Time Frame: baseline and at study completion, an average of 8 weeks
16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks.
baseline and at study completion, an average of 8 weeks
Appropriateness of Intervention Score
Time Frame: 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 (scores range from 4-20)
at study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Diana M Layne, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00120938
  • KL2TR001452 (U.S. NIH Grant/Contract)
  • UL1TR001450 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on A Program of SUPPORT-D (dementia)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe