Increasing Veterans' Social Engagement and Connectedness
NCT Number: NCT06467214
Acronym: CONNECTED
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Isolation
Interventions: BEHAVIORAL: CONNECTED|BEHAVIORAL: VET BEFRIENDING
Sponsor: VA Office of Research and Development
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 264
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-06-30
Locations: Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, 46202-2884, United States

Summary:
Social isolation is a negative social determinant of health that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. Increasing Veterans' Social Engagement and Connectedness involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address social determinants of health among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.

Primary Outcome Measures: Lubben Social Network Scale-6, The Lubben Social Network Scale-6 is a widely used, 6-item, self-reported measure of social isolation. It measures the frequency, size, and closeness of contact from respondents' social network. The scale has been used in both young and older adult populations, in racially diverse groups and in various settings and countries. Items are scored on a 6-point Likert scale, with total scores ranging from 0 (minimum) to 30 (maximum). Scores 12 indicate social isolation. The Lubben Social Network Scale-6 has strong internal consistency ( alpha = 0.83) and item reliability. There are no subscales., Baseline, 2, 4, 8 months
Secondary Outcome Measures: UCLA Loneliness Scale Short Form, The UCLA Loneliness Scale Short Form is a 6-item, self-reported measure, rated on a 4-point Likert Scale, ranging from 1 (never) to 4 (often). Items are summed for a total score ranging from 6 (minimum) to 24 (maximum). There is no subscale. The scale has demonstrated internal consistency. Higher scores indicate greater loneliness. The Cronbach coefficient alpha for this sample was 0.90., Baseline, 2, 4, 8 months|General Anxiety Disorder, General Anxiety Disorder-7, a validated self-reported measure of anxiety. It has 7 items rated on a 4-point Likert scale, 0=not at all to 3= nearly every day. The scale has a total summed score of 0 (minimum) to 21 (maximum). It has shown reliability, internal consistency ( = 0.89), and good sensitivity. A meaningful change is indicated by 5 or more points. A total score of 1-4 indicates minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, and 12-21 severe symptoms., Baseline, 2, 4, 8 months|Patient Health Questionnaire-9, The Patient Health Questionnaire-9 is a self-administered instrument used for screening, diagnosing, and monitoring the severity of depression. It has 9 items rated on a 4-point Likert Scale, ranging from 0=not at all to 3= nearly every day. The Patient Health Questionnaire-9 score is obtained by adding score for each item, for a total points ranging from 0 (minimum) to 27 (maximum). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression respectively. The internal reliability of the Patient Health Questionnaire-9 was excellent, with a Cronbach's alpha of 0.89., Baseline, 2, 4, 8 months|Multidimensional Scale of Perceived Social Support, Multi-dimensional Scale of Perceived Social Support scale is self-administered. It has 12-items, measured on a 7-point a Likert scale (1=very strongly disagree) to 7=(very strongly agree). Total scale score is the sum across all 12 items. It can also be calculated as a mean score (divided by 12). Summed total score ranges from 12 (minimum) to 84 (maximum). The scale has high internal consistency ( alpha = .88). There is no established population norms on the Multidimensional Scale of Perceived Social Support. There are 3 subscales. There are 3 subscales, with 4 item each. Their scores are the sum of the items divided by 4. Significant Other subscale (items 1, 2, 5, 10), Family subscale (3, 4, 8, 11), and Friends subscale (6, 7, 9, 12)., Baseline, 2, 4, 8 months|Social Connectedness Scale, The Social Connectedness Scale is a widely used 8-item measure that assesses aspects of belongingness, affiliation, and companionship. It is rated on a 6-point Likert scale, 1=strongly disagree to 6=strongly agree. The items are then summed for a total score, ranging from 8 (minimum) to 36 (maximum). A high score indicates more connectedness to others or reflects a greater sense of social connectedness. Internal reliability estimates for the 2 scales were .91 and .82, respectively., Baseline, 2, 4, 8 months|Columbia Suicide Severity Rating Scale Screener, "The Columbia Protocol, also known as the Columbia-Suicide Severity Rating Scale, supports suicide risk assessment through a series of simple, plain-language questions that anyone can ask. The answers help users identify whether someone is at risk for suicide, assess the severity and immediacy of that risk, and gauge the level of support that the person needs. The Columbia Suicide Severity Rating Scale Screener evidenced excellent internal consistency (ordinal alpha = .95). Users of the tool ask people:

Whether and when they have thought about suicide (ideation) What actions they have taken - and when - to prepare for suicide Whether and when they attempted suicide or began a suicide attempt that was either interrupted by another person or stopped of their own volition", As indicated by endorsement of suicidal ideation on Patient Health Questionnaire-9|Veterans RAND-12, The Veterans RAND 12 Item Health Survey is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. Its Internal consistency is high( s = .87 to .96).64, Baseline, 2, 4, 8 months|Life Engagement Test, The Life Engagement Test is a 6-item survey that measures the extent to which a person engages in activities that are valued (alpha = .80)61., Baseline, 2, 4, 8 months