- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05686681
Connect ME: Improving Social Connectedness
March 31, 2025 updated by: Renee.L.Pepin, Dartmouth-Hitchcock Medical Center
Improving Social Connectedness in Homebound Older Adults by Integrating a Brief Evidence-Based Telehealth Intervention Into Area Agency on Aging Services
To assess the reach and effectiveness of a behavioral activation intervention for older adults experiencing low social connectedness by Area Agency on Aging Staff.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Older adults (age>60) will be enrolled because they are the target population served by the home-delivered meals program and the target sample for this study.
Exclusion Criteria:
- Clinically significant depression (Patient Health Questionnaire; PHQ-9 ≥ 10) or active suicide risk (Columbia Suicide Severity Rating Scale; C-SSRS), or Cognitive Impairment (Blessed Orientation-Memory-Concentration Test>9)
- Clients who score 1 or greater on question 9 of the PHQ-9 will be further assessed for suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Clients will meet exclusion criteria for a positive response to any item
- We will exclude older adults with uncorrectable hearing or vision impairment rendering them unable to use the tele-conferencing equipment.
- Those who cannot speak English and have impaired decision-making capacity
- Adults unable to consent will be excluded
- Individuals who are not yet adults (infants, children, teenagers) will be excluded
- Pregnant women will be excluded
- Prisoners will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief Behavioral Activation for Improving Social Connectedness
Active, 6 session Brief Behavioral Activation for Improving Social Connectedness
|
Brief Behavioral Activation for Improving Social Connectedness (BBAISC): BBAISC was developed to address social connectedness. Grounded in Behavioral Activation (Lejuez et al., 2011), BBAISC is a structured, 6-session skill-building intervention that has 4 key elements (Pepin et al., 2020):
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Connectedness A, Baseline
Time Frame: before the intervention
|
10-item Duke Social Support Index (DSSI)
|
before the intervention
|
|
Social Connectedness A, Change from Baseline to Post Intervention
Time Frame: immediately following the intervention
|
10-item Duke Social Support Index (DSSI)
|
immediately following the intervention
|
|
Social Connectedness A, Change from Post Intervention to Follow Up
Time Frame: 12 weeks post intervention
|
10-item Duke Social Support Index (DSSI)
|
12 weeks post intervention
|
|
Social Connectedness B, Baseline
Time Frame: before the intervention
|
8-item PROMIS Social Isolation Scale
|
before the intervention
|
|
Social Connectedness B, Change from Baseline to Post Intervention
Time Frame: immediately following the intervention
|
8-item PROMIS Social Isolation Scale
|
immediately following the intervention
|
|
Social Connectedness B, Change from Post Intervention to Follow Up
Time Frame: 12 weeks post-intervention
|
8-item PROMIS Social Isolation Scale
|
12 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Reach
Time Frame: 12 Months
|
Reach will be determined by the proportion of eligible agency clients who agree participate in the study.
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Renée L Pepin, PhD, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
January 30, 2025
Study Completion (Actual)
January 30, 2025
Study Registration Dates
First Submitted
December 22, 2022
First Submitted That Met QC Criteria
January 9, 2023
First Posted (Actual)
January 17, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2025
Last Update Submitted That Met QC Criteria
March 31, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- STUDY02001734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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