Clinical trial NCT04919070: Connect for Caregivers
Official title: 'Connect for Caregivers' - Developing a Brief Intervention for Social Connectedness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Loneliness
Keywords: Social Connectedness
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-06-09
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Connect for Caregivers is a intervention feasibility pilot study. The purpose of the study is to pilot test a newly developed single session behavioral intervention to help caregivers of individuals with Alzheimer's Disease or related dementias gain understanding of the importance of increasing social connectedness, awareness of their personal barriers to connectedness, and knowledge of local resources for promoting connectedness.

Detailed description: Connect for Caregivers is a intervention feasibility pilot study. We use a mixed methods approach to initiate the development and testing process for a single session behavioral intervention to help caregivers gain understanding of the importance of increasing connectedness, awareness of their personal barriers to connectedness, and knowledge of local resources for promoting connectedness. The intervention-"Connect 4 Caregivers"-has three components: 1) psychoeducational materials on the importance of connectedness for health and wellbeing; 2) a card sort-based 'discussion prioritization tool' that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; 3) personalized resources to address the identified barriers/targets.

Aim 1 is to investigate whether Connect for Caregivers is associated with a signal for efficacy for changing connectedness by having n=5 caregivers complete the single session intervention and provide quantitative and qualitative data on their experience with the intervention and motivation to work on increasing their social connectedness (a signal for potential efficacy).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 50 yrs;
2. English speaking;
3. Caregiver (age 50 or older) for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
4. Elevated caregiving distress: Above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index (MCSI).
5. Social connectedness: UCLA Loneliness Scale: Short Form score of \>5.

Exclusion Criteria:

1. Primary language is not English;
2. Current problem drinking on the AUDIT-C (score of 5 or greater indicating exclusion);
3. Current non-alcohol psychoactive substance abuse (MINI Neuropsychiatric Interview), psychotic disorders (current and lifetime, MINI), bipolar disorder (MINI), and current mood disorder with psychotic features (MINI);
4. Significant cognitive impairment (MOCA \<22); and
5. Hearing problems that preclude completion of the intervention.

Primary outcomes:
measure: Perceived Autonomy
timeFrame: two weeks
measure: Perceived Competence Scale
timeFrame: two weeks
Secondary outcomes:
measure: Knowledge of Social Engagement
timeFrame: two weeks
measure: Loneliness
timeFrame: two weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: