Clinical trial NCT05501119: SUPPORT-D Intervention for Persons With Alzheimer's Disease and Their Caregivers
Official title: Palliative Care Telehealth Delivered Program of SUPPORT-D Intervention for Persons With Alzheimer's Disease and Caregivers Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-08-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)
* No diagnosis of cognitive impairment

Exclusion Criteria:

* Inability or unwillingness to provide informed consent

Primary outcomes:
measure: Change in Alzheimer's Disease Knowledge Scale (ADKS) Score
timeFrame: baseline, at study completion, an average of 8 weeks
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: at study completion, an average of 8 weeks
measure: Feasibility Score
timeFrame: at study completion, an average of 8 weeks
measure: Change Zarit Caregiver Burden Score
timeFrame: baseline, at study completion, an average of 8 weeks
measure: Change in Perceived Stress Scale Score
timeFrame: baseline and at study completion, an average of 8 weeks
measure: Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score
timeFrame: baseline and at study completion, an average of 8 weeks
measure: Change in Self-efficacy for Caregiving Score
timeFrame: baseline and at study completion, an average of 8 weeks
measure: Change in Safety Assessment Scale Score
timeFrame: baseline and at study completion, an average of 8 weeks
measure: Appropriateness of Intervention Score
timeFrame: at study completion, an average of 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Diana M Layne, PhD
role: PRINCIPAL_INVESTIGATOR
References: