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

NCT05501119 | Completed Results

• 3 other identifiers: Pro00120938KL2TR001452UL1TR001450
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (9)

• 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

• 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 (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

  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

  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

  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

  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

  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

Study Arms (1)

SUPPORT-D Group

EXPERIMENTAL

Behavioral: A Program of SUPPORT-D (dementia)

Interventions

A Program of SUPPORT-D (dementia) BEHAVIORAL

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).

SUPPORT-D Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Limitations and Caveats

Many care recipients did not believe PROMIS measures applied to them so they did not complete those measures. Some participants chose to not complete all survey items.

Results Point of Contact

• Title: Dr. Diana Layne
• Organization: Medical University of South Carolina

layne@musc.edu

(843) 792-8515

Study Officials

• Diana M Layne, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 15, 2022
• Study Start: January 27, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)