Community-Based Social Connection Intervention Program to Improve Cardiovascular and Brain Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversidad de Especialidades Espiritu Santo
About this trial
This study evaluates the effectiveness of a community-based social connection intervention program (SCIP) designed to reduce social isolation and loneliness and improve cardiovascular and brain health among older adults living in rural Ecuador. Loneliness and social isolation are recognized risk factors for poor cardiovascular outcomes, cognitive decline, depression, and reduced quality of life. However, evidence from low- and middle-income countries, particularly in rural Latin American settings, remains limited. This protocol describes a quasi-experimental, longitudinal study conducted in three rural villages that have been part of a long-standing population-based cohort.
The intervention will be implemented in one community and compared with two similar communities that will continue receiving usual community activities. SCIP consists of three components: (1) monthly community activities and educational talks designed to promote social participation; (2) monthly peer-support group sessions facilitated by trained personnel; and (3) individualized home-based coaching delivered twice per month, incorporating principles of Social Cognitive Theory and Cognitive Behavioral Therapy. The program aims to strengthen social networks, enhance coping skills, and promote healthier behaviors.
Participants aged 60 years and older will be enrolled and followed for 12 months. Assessments will occur at baseline, 6 months, and 12 months. Primary outcomes include changes in social isolation (Lubben Social Network Scale-6) and loneliness (De Jong Gierveld Scale). Secondary outcomes include cardiovascular health (Life's Essential 8), sleep quality (Pittsburgh Sleep Quality Index), cognitive performance (Montreal Cognitive Assessment), depressive symptoms (DASS-21), and quality of life (SF-36). Exploratory outcomes include incident stroke, cardiovascular events, and mortality, monitored through ongoing community surveillance.
This study will generate evidence on the feasibility and impact of a culturally adapted, community-based intervention to promote social connection and healthy aging in a resource-limited rural setting. Findings may inform scalable public health strategies for older adults in similar contexts.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Social Connection Intervention Program (SCIP): Community activities, peer-support groups, and home-based coaching to reduce social isolation and loneliness.
Other interventionThe Social Connection Intervention Program (SCIP) is a 12-month, community-based program designed to reduce social isolation and loneliness among older adults in rural Ecuador. The intervention includes three components: (1) monthly community activities and educational talks to promote social participation and health awareness; (2) monthly peer-support group sessions facilitated by trained personnel to enhance emotional support and shared problem-solving; and (3) twice-monthly individualized home-based coaching sessions incorporating principles of Social Cognitive Theory and Cognitive Behavioral Therapy to strengthen coping skills, goal-setting, and healthy behaviors. The program is delivered in the intervention community, while comparison c
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: intervention community (SCIP)Experimental treatment 1 intervention
Group B: controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in LSNS-6 and De Jong Gierveld Loneliness Scale scores
The primary outcome is the change in social isolation and loneliness from baseline to 12 months. Social isolation will be measured using the Lubben Social Network Scale-6 (LSNS-6), which assesses the size and frequency of contact within family and friendship networks. Loneliness will be measured using the De Jong Gierveld Loneliness Scale, which evaluates emotional and social dimensions of perceived loneliness. Scores will be collected at baseline, 6 months, and 12 months. The primary analysis will compare changes over time between the intervention community receiving the Social Connection Intervention Program (SCIP) and the comparison communities receiving usual activities.
Time frame
12 monthsSecondary outcomes
1
Change in Life's essential 8 cardiovascular health score
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) score, which includes diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure. Scores will be collected at baseline, 6 months, and 12 months. The analysis will compare changes between intervention and control communities.
Time frame
12 months2
Change in Monreal Cognitive Assessment (MoCA) score
Cognitive function will be measured using the Montreal Cognitive Assessment (MoCA). Scores will be collected at baseline and 12 months. The analysis will compare changes between intervention and control communities.
Time frame
12 months3
Change in Pittsburgh Sleep Quality Index (PSQI) score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Scores will be collected at baseline and 12 months. The analysis will compare changes between intervention and control communities.
Time frame
12 months4
Change in Depression, Anxiety and Stress Scale (DASS-21) score
Mood symptoms will be assessed using the Depression, Anxiety, and Stress Scale (DASS-21). Scores will be collected at baseline and 12 months. The analysis will compare changes between intervention and control communities.
Time frame
12 monthsOther outcomes
1
Incidence of stroke, cardiovascular events, and mortality
Incident stroke, cardiovascular events, vascular mortality, and all-cause mortality will be monitored through active surveillance and community health records. Events will be compared between intervention and control communities.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de Especialidades Espiritu Santo
Lead sponsor
University of Miami
Collaborator
Source ClinicalTrials.gov