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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501119
• Other study ID #: Pro00120938
• Secondary ID: KL2TR001452UL1TR
• Status: Completed
• Phase: N/A
• Start date: January 27, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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