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

NCT07319663 | Recruiting

• 1 other identifier: UniversidadEES
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Isolation in Older Adults; Loneliness; Stroke; Cognitive Decline

Keywords

Social isolation; Loneliness; Social support; Community Health Services; Rural population; Aged

Outcome Measures

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.

  12 months

Secondary Outcomes (5)

• Change in Life's essential 8 cardiovascular health score

  12 months

• Change in Monreal Cognitive Assessment (MoCA) score

  12 months

• Change in Pittsburgh Sleep Quality Index (PSQI) score

  12 months

• Change in Depression, Anxiety and Stress Scale (DASS-21) score

  12 months

• Change in SF36 Quality of life score

  12 months

Other Outcomes (1)

• Incidence of stroke, cardiovascular events, and mortality

  12 months

Study Arms (2)

intervention community (SCIP)

EXPERIMENTAL

Participants in this community receive the Social Connection Intervention Program (SCIP), which includes monthly community activities and educational talks, monthly peer-support group sessions, and twice-monthly individualized home-based coaching. The program is delivered over 12 months to reduce social isolation and loneliness and promote cardiovascular and brain health.

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

control

NO INTERVENTION

Interventions

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

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

intervention community (SCIP)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older Permanent resident of the community for at least one year Able to provide written informed consent Able to participate in community activities and home-based assessments No plans to relocate during the 12-month follow-up

You may not qualify if:

• Severe disability that prevents participation in study activities Diagnosed dementia, major psychiatric illness, or severe cognitive impairment History of stroke with significant functional limitation Terminal illness or medical condition that precludes follow-up

Sponsors & Collaborators

• University of Miami: collaborator
• Universidad de Especialidades Espiritu Santo: lead

Study Sites (1)

Universidad Espiritu Santo

Samborondón, Guayas, 09231, Ecuador

RECRUITING

Related Publications (2)

• Taylor HO, Cudjoe TKM, Bu F, Lim MH. The state of loneliness and social isolation research: current knowledge and future directions. BMC Public Health. 2023 Jun 1;23(1):1049. doi: 10.1186/s12889-023-15967-3.

  PMID: 37264355 RESULT

• Del Brutto VJ, Leal G, Mera RM, Rumbea DA, Abad MJ, Del Brutto OH. Community-based social connection intervention programme to improve cardiovascular and brain health in older adults in rural Ecuador: study protocol for a quasi-experimental trial. BMJ Open. 2026 Jun 1;16(6):e118544. doi: 10.1136/bmjopen-2026-118544.

  PMID: 42225361 DERIVED

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction; Social Isolation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Oscar H Del Brutto, MD

  Proyecto Atahualpa

  STUDY CHAIR

Central Study Contacts

Oscar H Del Brutto, MD

CONTACT

593-997476984; oscardelbrutto@hotmail.com

Denisse A Rumbea, MHA

CONTACT

593-994013452; denisse_rumbea@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label community-based intervention; no masking was feasible due to the nature of the program.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, the Atahualpa Project

Model Details: This study uses a quasi-experimental, community-based longitudinal design to evaluate the impact of a social connection intervention on older adults in rural Ecuador. One community receives the intervention, while two comparable communities serve as non-randomized comparison groups. Allocation is based on pre-existing community of residence. Participants are followed for 12 months with assessments at baseline, 6 months, and 12 months. The intervention includes monthly community activities, monthly peer-support groups, and twice-monthly home-based coaching. Outcomes include social isolation, loneliness, cardiovascular health, cognition, sleep, mood, and quality of life.

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)