[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617518":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":37,"responsibleParty":55,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":17,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":17,"enrollmentInfo":72,"targetDuration":17,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":40,"whyStopped":17,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Universidad de Especialidades Espiritu Santo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Social Connection Intervention Program (SCIP): Community activities, peer-support groups, and home-based coaching to reduce social isolation and loneliness.",{"label":15,"type":16,"description":17,"interventionNames":17},"control","NO_INTERVENTION",null,[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":17},"Social 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",[9],[24],{"name":25,"affiliation":26,"role":27},"Oscar H Del Brutto, MD","Proyecto Atahualpa","STUDY_CHAIR",[29,33],{"name":25,"role":30,"phone":31,"phoneExt":17,"email":32},"CONTACT","593-997476984","oscardelbrutto@hotmail.com",{"name":34,"role":30,"phone":35,"phoneExt":17,"email":36},"Denisse A Rumbea, MHA","593-994013452","denisse_rumbea@hotmail.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Universidad Espiritu Santo","RECRUITING","Samborondón","Guayas","09231","Ecuador","EC",{"type":47,"coordinates":48},"Point",[49,50],-79.72566,-1.96071,{"lat":50,"lon":49},[53,54],{"name":25,"role":30,"phone":31,"phoneExt":17,"email":32},{"name":34,"role":30,"phone":17,"phoneExt":17,"email":36},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Oscar H. Del Brutto","Director, the Atahualpa Project",[60],{"name":61,"class":6},"University of Miami","100617518","community-based-social-connection-intervention-program-to-improve-cardiovascular-and-brain-health-100617518",false,"NCT07319663","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","Inclusion Criteria:\n\nAge 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\n\nExclusion Criteria:\n\nSevere 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\n\n\\-",true,"ALL","60 Years",{"count":73,"type":74},500,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.\n\nThe 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.\n\nParticipants 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.\n\nThis 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.",[80,81,82,83],"Social Isolation in Older Adults","Loneliness","Stroke","Cognitive Decline",[85,81,86,87,88,89],"Social isolation","Social support","Community Health Services","Rural population","Aged","2026-06-09",{"date":92,"type":93},"2026-06-11","ACTUAL",{"date":95,"type":93},"2026-06-01",{"date":97,"type":74},"2027-06-01",{"name":5,"class":6},1]