Trial Outcomes & Findings for Connect for Caregivers (NCT NCT04919070)

NCT ID: NCT04919070

Last Updated: 2022-12-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

two weeks

Results posted on

2022-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Connect for Caregivers Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; 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 and targets. Connect for Caregivers: 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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Connect for Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Connect for Caregivers n=5 Participants Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; 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 and targets. Connect for Caregivers: 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.
Age, Continuous	62.89 years STANDARD_DEVIATION 4.22 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Perceived Autonomy	21.8 score on a scale STANDARD_DEVIATION 1.66 • n=5 Participants
Perceived Competence	16.8 score on a scale STANDARD_DEVIATION 1.28 • n=5 Participants
Knowledge of Social Engagement	14.8 score on a scale STANDARD_DEVIATION 2.59 • n=5 Participants
UCLA Loneliness Scale	49.6 score on a scale STANDARD_DEVIATION 10.85 • n=5 Participants

PRIMARY outcome

Timeframe: two weeks

Outcome measures

Outcome measures
Measure	Connect for Caregivers n=5 Participants Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; 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 and targets. Connect for Caregivers: 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.
Perceived Autonomy	21.2 score on a scale Standard Deviation 1.32

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Connect for Caregivers n=5 Participants Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; 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 and targets. Connect for Caregivers: 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.
Perceived Competence Scale	16.4 score on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Connect for Caregivers n=5 Participants Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; 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 and targets. Connect for Caregivers: 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.
Knowledge of Social Engagement	15.6 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Connect for Caregivers n=5 Participants Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; 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 and targets. Connect for Caregivers: 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.
Loneliness	53.4 score on a scale Standard Deviation 6.11

Adverse Events

Connect for Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sally Norton

University of Rochester

Phone: 5852759814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place