RecruitingNot ApplicableNCT07319663

Community-Based Social Connection Intervention Program to Improve Cardiovascular and Brain Health

Quasi-experimental Community-Based Social Connection Intervention Program to Improve Cardiovascular and Brain Health in Older Adults Living in Rural Ecuador


Sponsor

Universidad de Especialidades Espiritu Santo

Enrollment

500 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Social Connection Intervention Program (SCIP): Community activities, peer-support groups, and home-based coaching to reduce social isolation and loneliness. for people with cognitive decline, loneliness, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSocial Connection Intervention Program (SCIP): Community activities, peer-support groups, and home-based coaching to reduce social isolation and loneliness.

The 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


Locations(1)

Universidad Espiritu Santo

Samborondón, Guayas, Ecuador

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NCT07319663


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