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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Being tested

A Program of SUPPORT-D (dementia)

Medical subject headings

Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• A Program of SUPPORT-D (dementia)Behavioural

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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)

   Measured: baseline, at study completion, an average of 8 weeks

2. 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)

   Measured: at study completion, an average of 8 weeks

3. 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)

   Measured: at study completion, an average of 8 weeks

4. 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)

   Measured: baseline, at study completion, an average of 8 weeks

5. 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)

   Measured: baseline and at study completion, an average of 8 weeks

6. 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)

   Measured: baseline and at study completion, an average of 8 weeks

7. 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)

   Measured: baseline and at study completion, an average of 8 weeks

8. 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.

   Measured: baseline and at study completion, an average of 8 weeks

9. 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)

   Measured: at study completion, an average of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Aug 2022
2. Study start27 Jan 2023
3. Primary completion1 Apr 2024
4. Study completion1 Apr 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
• More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.