Quasi-experimental Community-Based Social Connection Intervention Program to Improve Cardiovascular and Brain Health in Older Adults Living in Rural Ecuador
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Social isolation and loneliness
研究概览
简要总结
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.
详细描述
Loneliness and social isolation are increasingly recognized as major public health concerns, particularly among older adults. These conditions are associated with elevated risks of cardiovascular disease, cognitive decline, depression, sleep disturbances, reduced quality of life, and premature mortality. Although evidence from high-income countries supports the use of community-based interventions to enhance social connection, there is limited research in low- and middle-income countries and almost no data from rural Latin American settings. The Social Connection Intervention Program (SCIP) was developed to address this gap by adapting evidence-based strategies to the cultural, social, and resource context of rural Ecuador.
Study Design and Setting: This is a quasi-experimental, longitudinal study conducted in three rural villages in coastal Ecuador that have participated in a population-based cohort for more than 12 years. One community (Atahualpa) will receive the intervention, while two comparable communities (El Tambo and Prosperidad) will serve as comparison sites. Allocation is based on pre-existing community of residence. The study will follow participants for 12 months, with assessments at baseline, 6 months, and 12 months.
Participants: Eligible participants are adults aged 60 years or older who have lived in the community for at least one year, have no plans to relocate, and do not have disability, dementia, stroke, or major psychiatric illness. Written informed consent will be obtained from all participants. Recruitment will leverage the existing cohort infrastructure, which has historically achieved high retention rates.
Intervention: SCIP consists of three integrated components: 1. Community Activities and Educational Talks: Monthly group activities designed to promote social participation, health education, and community engagement. Activities include cultural events, group discussions, and interactive workshops; 2. Peer-Support Groups: Monthly small-group sessions facilitated by trained personnel, focusing on emotional support, shared experiences, and collective problem-solving. These sessions aim to strengthen interpersonal connections and reduce feelings of loneliness , and 3. Home-Based Coaching: Twice-monthly individualized coaching sessions delivered in participants' homes. The coaching incorporates principles of Social Cognitive Theory and Cognitive Behavioral Therapy, emphasizing goal-setting, self-efficacy, coping strategies, and behavior change to support healthier lifestyles and social engagement.
The comparison communities will continue with their usual activities and will not receive SCIP during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open-label community-based intervention; no masking was feasible due to the nature of the program.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
control
intervention community (SCIP)
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.
干预措施: Social Connection Intervention Program (SCIP): Community activities, peer-support groups, and home-based coaching to reduce social isolation and loneliness. (Other)
结局指标
主要结局
Social isolation and loneliness
时间窗: 12 months
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.
Change in LSNS-6 and De Jong Gierveld Loneliness Scale scores
时间窗: 12 months
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.
Social isolation and loneliness
时间窗: one year
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. Both instruments are validated for use in older adult populations. 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.
次要结局
- Cardiovascular health(12 months)
- Cognitive performance(12 months)
- Sleep quality(12 months)
- Mood symptoms(12 months)
- Quality of life(12 months)
- 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)
研究者
Oscar H. Del Brutto
Director, the Atahualpa Project
Universidad de Especialidades Espiritu Santo