Connect ME: Improving Social Connectedness

Social Connectedness Clinical Trial

Official title:

Improving Social Connectedness in Homebound Older Adults by Integrating a Brief Evidence-Based Telehealth Intervention Into Area Agency on Aging Services

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686681
• Other study ID #: STUDY02001734
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Renée L Pepin, PhD
• Phone: 6036533454
• Email: Renee.L.Pepin[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Social Connectedness

Intervention

Behavioral:
• 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): Psychoeducation: Psychoeducation focused on homebound status, social connectedness, and associated changes in behavior. Behavioral Activation intervention rationale: Framing how changing behavior can positively impact social connectedness (i.e., improve social connectedness and reduce loneliness). Exploration of life areas, values, and activities: Focused on identifying life areas and values most relevant to the participant. Then, these values are used to generate activities that are aligned with those values. Activity monitoring and planning: Participants are encouraged to schedule and organize their day based on what is important rather than their current mood or feeling state.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Connectedness A, Baseline	10-item Duke Social Support Index (DSSI)	before the intervention
Primary	Social Connectedness A, Change from Baseline to Post Intervention	10-item Duke Social Support Index (DSSI)	immediately following the intervention
Primary	Social Connectedness A, Change from Post Intervention to Follow Up	10-item Duke Social Support Index (DSSI)	12 weeks post intervention
Primary	Social Connectedness B, Baseline	8-item PROMIS Social Isolation Scale	before the intervention
Primary	Social Connectedness B, Change from Baseline to Post Intervention	8-item PROMIS Social Isolation Scale	immediately following the intervention
Primary	Social Connectedness B, Change from Post Intervention to Follow Up	8-item PROMIS Social Isolation Scale	12 weeks post-intervention
Secondary	Intervention Reach	Reach will be determined by the proportion of eligible agency clients who agree participate in the study.	12 Months