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Clinical Trials/NCT05501119
NCT05501119
Completed
N/A

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

Medical University of South Carolina1 site in 1 country58 target enrollmentJanuary 27, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Medical University of South Carolina
Enrollment
58
Locations
1
Primary Endpoint
Change in Alzheimer's Disease Knowledge Scale (ADKS) Score
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2023
End Date
April 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diana Layne

Assistant Professor

Medical University of South Carolina

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)

Exclusion Criteria

  • Inability or unwillingness to provide informed consent

Outcomes

Primary Outcomes

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)

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)

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)

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)

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)

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)

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)

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.

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)

Study Sites (1)

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