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Completed

NCT Number: NCT04919070

Connect for Caregivers

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.

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Key information

Conditions

Social Isolation Behavior Loneliness Social Behavior

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester, Rochester, New York, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 50 yrs;
  • English speaking;
  • Caregiver (age 50 or older) for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
  • 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).
  • Social connectedness: UCLA Loneliness Scale: Short Form score of >5.

Exclusion criteria

  • Primary language is not English;
  • Current problem drinking on the AUDIT-C (score of 5 or greater indicating exclusion);
  • 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);
  • Significant cognitive impairment (MOCA <22); and
  • Hearing problems that preclude completion of the intervention.

Treatment and study plan

Connect for Caregivers

Behavioral

The intervention being studied is a single session guided behavioral intervention to improve social connectedness in caregivers of individuals with ADRD. The intervention, Connect for Caregivers, provides psychoeducation on the importance of social connectedness for health and well-being, includes a card-sort process to identify and prioritize barriers to connectedness, and provides personalized resources and strategies for caregivers to use to increase their social connectedness.

Primary outcomes

  1. Perceived Autonomy

    Time frame: two weeks

    This is a self-report measure that assesses a mechanism posited by Self-Determination Theory to increase motivation for healthy behaviors. It has 6 items, a range from 6-30, and higher scores indicate greater perceived autonomy.

  2. Perceived Competence Scale

    Time frame: two weeks

    This is a self-report measure that assesses a mechanism posited by Self-Determination Theory to increase motivation for healthy behaviors. It has 7 items, a range from 7-35, and higher scores indicate greater perceived competence.

Secondary outcomes

  1. Knowledge of Social Engagement

    Time frame: two weeks

    This is a self-report measure that assesses a subject's knowledge of the importance of social connections. It has 4 items, a range from 4-20, and higher scores indicate greater knowledge.

  2. Loneliness

    Time frame: two weeks

    UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

'Connect for Caregivers' - Developing a Brief Intervention for Social Connectedness

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2021
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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