CompletedNot Applicable

Connect ME: Improving Social Connectedness

United States11 participantsStarted 2023-05-01

Plain-language summary

To assess the reach and effectiveness of a behavioral activation intervention for older adults experiencing low social connectedness by Area Agency on Aging Staff.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Social Connectedness A, Baseline

Timeframe: before the intervention

Social Connectedness A, Change from Baseline to Post Intervention

Timeframe: immediately following the intervention

Social Connectedness A, Change from Post Intervention to Follow Up

Timeframe: 12 weeks post intervention

Social Connectedness B, Baseline

Timeframe: before the intervention

Social Connectedness B, Change from Baseline to Post Intervention

Timeframe: immediately following the intervention

Social Connectedness B, Change from Post Intervention to Follow Up

Timeframe: 12 weeks post-intervention

Trial details

NCT IDNCT05686681

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Social Connectedness trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Social Connectedness A, Baseline

Timeframe: before the intervention

Social Connectedness A, Change from Baseline to Post Intervention

Timeframe: immediately following the intervention

Social Connectedness A, Change from Post Intervention to Follow Up

Timeframe: 12 weeks post intervention

Social Connectedness B, Baseline

Timeframe: before the intervention

Social Connectedness B, Change from Baseline to Post Intervention

Timeframe: immediately following the intervention

Social Connectedness B, Change from Post Intervention to Follow Up

Timeframe: 12 weeks post-intervention