About this trial
This project aims to culturally adapt the SHARE program for African-Americans in early-moderate stage dementia and their care partner. Upon completion of the adaptation, a pilot randomized-control trial wil be confucted to compare the adaptaed SHARE program versus usual care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
African American dyads (both the caregivers and the care-recipient, an individual with an early-stage memory impairing condition (e.g., Alzheimer's disease, vascular dementia, cognitive impairment, etc.)
Care-recipient lives at home.
The caregiver (CG) and/or the person with dementia (PWD), or symptoms of memory loss must identify as African American.
PWD must be at least 50 years old and CGs 18 or older,
Disqualifiers
A mental health condition (e.g., schizophrenia, bipolar disorder, major depression)
A traumatic brain injury
Intellectual or developmental disability
Individuals experiencing extreme difficulty adjusting and coping to the diagnosis • Individuals living in an institutional setting
Trial design
Parallel
Treatments tested in this trial
5+1 Adapted, early-stage dyadic care planning intervention
BehavioralThe intervention group will receive the adapted SHARE Dyadic program, consisting of five, 60-90-minute curriculum-guided sessions with a SHARE Counselor, plus one optional family session.
Counseling session and printed resources
BehavioralControl group participants will receive a treatment as usual equivalent: a single, standardized educational and resource session with a packet of information.
Treatment groups
Trial outcomes
Primary outcomes
Session length
SHARE counselors will report length of each session, and we will determine the number of sessions conducted were within 60-90 minutes - the prescribed treatment protocol.
Attendance
SHARE counselors will report the number of sessions attended out of 6 treatment sessions offered.
Attrition
We will assess the number of caregivers and PLWD retained at follow-up
Satisfaction with session
Caregivers and PLWD will be asked about their satisfaction with SHARE regarding the: 1) experience; 2) counselor; 3) materials; 4) sessions; 5) postintervention relationship functioning.
Secondary outcomes
Dyadic Relationship Scale (DRS) (Clinical Outcomes (Distal Effects; Secondary))
The Dyadic Relationship Scale consists of 28 items that asks care partners and PLWD how often of the time (15-items), and how often in the past month (13-items), they think a statement applies to their relationship. Responses are (0-3) ranging from "All or nearly all of the time" to "None or almost none of the time". Ranges are a total of 0-84, with higher scores indicating more positive dyadic relationship.
Personal and Instrumental Activities of Daily Living (PIADL)
The Personal and Instrument Activities of Daily Living is a an 18-item measure that asks care partners to rate the PLWD ability to perform daily activities. Responses are (1) Does by self/ Needs no help, (2) Needs reminders/ Needs a little help, (3) Needs help most of the time, and (4) Needs help all the time (unable to do activity). Range is from 18-72, with lower scores indicating less ability of PLWD to perform daily activities independently.
Emotional-Intimacy Disruptive Behavior Scale (EIDBS)
The Emotional-Intimacy Disruptive Behavior Scale is a an 8-item measure to asks care givers and PLWD to assess the extent care partners with hold or distort symptoms or feelings to protect their care partner. Response options are (1) None of the time, (2) Some of the time, (3) Much of the time, (4) Most or all of the time. Range is from 8-32, with higher scores indicating higher distortions of feelings
Dementia Quality of Life +/- Affect
Caregivers and PLWD will be asked six positive/six negative affect indicators.
Other outcomes
Self-Care education (Mechanisms (Proximal Effects; Secondary))
SHARE counselors will report on dyad's self-care strengths and challenges after sessions 1 \& 4 of the treatment intervention.
Communication skills (Mechanisms (Proximal Effects; Secondary))
Communication skills are 4-items that counselors respond to after each session of the treatment intervention to rate the degree of which care partner and PLWD communicated with the counselor, as well as to rate the quality and balance of amount of talking that occurred during the sessions. Response options range from 1 "Not at all" to 7 "very", with higher scores indicating better communication.
Knowledge of Available Service; Service Availability Measure (Mechanisms (Proximal Effects; Secondary))
The Knowledge of Available Service subscale of the Service Availability Measure is a 14-item measure of the PLWD and their care partner's knowledge of different community of mental health services available. Response are (1) yes and (0) no. Range is 0-14, with higher scores indicating higher knowledge of services available.
Use of Services; Service Availability Measure (Mechanisms (Proximal Effects; Secondary))
The Use of Services subscale of the Service Availability Measure is a 14-item measure of the PLWD and their care partner's use of different community of mental health services available in the past 3 months. Response are (1) yes and (0) no. Range is 0-14, with higher scores indicating higher use of services available.
Sponsors and contacts
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Benjamin Rose Institute on Aging
Lead sponsor
National Institute on Aging (NIA)
Collaborator