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Connect for Caregivers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04919070
Enrollment
5
Registered
2021-06-09
Start date
2021-06-28
Completion date
2021-08-27
Last updated
2022-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness, Social Isolation

Keywords

Social Connectedness

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).

Interventions

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Rochester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perceived Autonomytwo weeksThis 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.
Perceived Competence Scaletwo weeksThis 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

MeasureTime frameDescription
Knowledge of Social Engagementtwo weeksThis 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.
Lonelinesstwo weeksUCLA 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
5
Total5

Baseline characteristics

CharacteristicConnect for Caregivers
Age, Continuous62.89 years
STANDARD_DEVIATION 4.22
Knowledge of Social Engagement14.8 score on a scale
STANDARD_DEVIATION 2.59
Perceived Autonomy21.8 score on a scale
STANDARD_DEVIATION 1.66
Perceived Competence16.8 score on a scale
STANDARD_DEVIATION 1.28
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
5 participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
0 Participants
UCLA Loneliness Scale49.6 score on a scale
STANDARD_DEVIATION 10.85

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 5
other
Total, other adverse events
0 / 5
serious
Total, serious adverse events
0 / 5

Outcome results

Primary

Perceived Autonomy

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.

Time frame: two weeks

ArmMeasureValue (MEAN)Dispersion
Connect for CaregiversPerceived Autonomy21.2 score on a scaleStandard Deviation 1.32
Primary

Perceived Competence Scale

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.

Time frame: two weeks

ArmMeasureValue (MEAN)Dispersion
Connect for CaregiversPerceived Competence Scale16.4 score on a scaleStandard Deviation 2
Secondary

Knowledge of Social Engagement

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.

Time frame: two weeks

ArmMeasureValue (MEAN)Dispersion
Connect for CaregiversKnowledge of Social Engagement15.6 score on a scaleStandard Deviation 2.3
Secondary

Loneliness

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).

Time frame: two weeks

ArmMeasureValue (MEAN)Dispersion
Connect for CaregiversLoneliness53.4 score on a scaleStandard Deviation 6.11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026