Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 5:22 PM
Study NCT ID:
NCT06829758
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compartiendo Salud: Community-Based Intervention for Loneliness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Feeling of unwanted loneliness', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'It was measured using the "UCLA (University of California at Los Angeles) Loneliness scale" test validated in Spain. This instrument is based on three dimensions: Relational connection; Social connection; and Self-perceived isolation. It uses a 4-point scale ranging from "Never" to "Frequently" for responses 10 items. Scores above 30 correspond to "No loneliness", between 20 and 30 mean "Moderate loneliness" and less than 20 points is "Severe loneliness"'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Social risk', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'It was measured using the Gijón Social risk detection questionnaire. It assesses family and economic situations, housing, social relations and support from social networks. It uses a 5-point scale ranging from best to worse situation, for responses 5 items. Scores: Good/Acceptable social situation: from 5 to 9 points; Social risk: from 10 to 14; and social problem: more than 15'}, {'measure': 'Number of Participants with Low Perceived social support', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'It was measured with Duke\'s questionnaire. It assesses perceived social support and consists of 11 items, each one assessed with a Likert scale from 1 to 5. Scores equal to or higher than 32 indicate "Normal support", whereas less than 32 points means "Low perceived social support"'}, {'measure': 'Number of Participants with Anxiety or depression', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': "They were assessed using Goldberg's questionnaire with two subscales: Anxiety and Depression. Each of them is structured with 4 initial screening items to determine the probability of a mental disorder and a second group with 5 items that are only formulated if positive answers are given to the screening questions (at least 2 in the Anxiety subscale and at least 1 in the Depression subscale). The type of response of the questionnaire is dichotomous (Yes/No). The cut-off points are as follows: scores equal to or higher than 4 for the Anxiety subscale; and values equal to or higher than 2 for Depression. In the geriatric population, it has been proposed to use it as a single scale, with a cut-off point equal to or higher than 6"}, {'measure': 'Number of Participants with Risk of loneliness', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Nursing diagnosis "Risk of loneliness" (Yes/No) and presence/absence of each of its defining characteristics: Affective deprivation; Emotional Deprivation; Physical isolation; Social isolation.'}, {'measure': 'Number of Participants with Social Isolation', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Nursing diagnosis "Social Isolation" (Yes/No) and presence/absence of each of its defining characteristics: Low social activity levels; Change in physical aspect; Explicit dissatisfaction with social connections; Social reclusion; Social behaviour inconsistent with cultural norms; Reporting feeling insecure in public; Reduced eye contact.'}, {'measure': 'Number of Participants with Smoking', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'The smoking assessment included in the habits module of the electronic clinical history of Primary Health Care of the Canary Islands Health Service Drago-AP will be used: Non-smoker/Smoker in undetermined phase/Smoker in pre-contemplation phase (consonant)/Smoker in contemplation phase (dissonant)/Smoker in preparation phase/Smoker in action phase/Smoker in maintenance phase/Former smoker since 1-10 years/Former smoker since more than 10 years/Passive smoker'}, {'measure': 'Number of Participants with alcoholism', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'The alcoholism assessment included in the habits module of the electronic clinical history of Primary Health Care of the Canary Islands Health Service Drago-AP will be used: Non-drinker/Moderate drinker/Risk drinker/Drinking problem'}, {'measure': 'Number of Participants without sleep problems', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Sleep problem (Yes/No)'}, {'measure': 'Number of Participants with caregiver', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Dichotomous variables (Yes/No)'}, {'measure': 'Number of Participants belonging to an organized group', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Dichotomous variables (Yes/No)'}, {'measure': 'Number of Participants what does it feel like Integrated in the area where they live', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Dichotomous variables (Yes/No)'}, {'measure': 'Number of Participants with Activities in free and/or leisure time', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Dichotomous variables (Yes/No)'}, {'measure': 'Number of Participants with Home-based care; Social assistance', 'timeFrame': 'Pre- and post- intervention (at three months)', 'description': 'Dichotomous variables (Yes/No)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Social Support', 'Community Health Nursing', 'Health Education', 'Aged'], 'conditions': ['Loneliness']}, 'descriptionModule': {'briefSummary': 'Unwanted loneliness is the gap between the social relations a person has and those they want. The main objective of this research is to assess the impact of a multidimensional community-based intervention on the feeling of unwanted loneliness in the population over the age of 65 years old, who living alone, under social risk or socially isolated living in the La Palma island.', 'detailedDescription': "Loneliness is strongly associated with a significant impact on physical health, depression and may in fact be an independent risk factor for depression. Fur-thermore, it is negatively associated with healt problems, like higher blood pressure, poorer sleep, immune responses to stress, and poorer cognition over time in the elderly. The absence of personal connections is related to the adoption of worse life habits and to increased morbidity, with the consequent higher risk of suf-fering cardiovascular and endocrine diseases, mental health pathologies and risk of falls.\n\nThe secondary objectives proposed are as follows: Increasing the number of opportunities for social interaction during the intervention; Contributing tools to improve the participants' social skills in the intervention; Fostering self-care and healthy habits in the participants; Reducing maladaptive thoughts; Educating on sleep hygiene measures and non-pharmacological treatments.\n\nThe null hypothesis (H0) of this research is that in the population under study, the proposed multidimensional community intervention will not significantly impact the feeling of unwanted loneliness and the health management of these subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People over the age of 65 and living alone\n* Nursing diagnosis of social risk\n* Nursing diagnosis of social isolation\n\nExclusion Criteria:\n\n* presenting moderate/severe cognitive decline or Pfeiffer scores above 6\n* individuals with uncorrected hearing deficits that hinder group interaction\n* participants not subjected to the pre- and post-interventions measurements\n* participants that do not take part in at least four of the five sessions scheduled'}, 'identificationModule': {'nctId': 'NCT06829758', 'acronym': 'SoledadLP', 'briefTitle': 'Compartiendo Salud: Community-Based Intervention for Loneliness', 'organization': {'class': 'OTHER', 'fullName': 'Servicio Canario de Salud'}, 'officialTitle': 'Effectiveness of a Community Intervention in Reducing the Feeling of Unwanted Loneliness, Social Risk, and Social Isolation in the Population Over 65 Years Old in La Palma, Focusing on Healthy Habits, Sleep Hygiene, and Digital Literacy', 'orgStudyIdInfo': {'id': 'CHUC_2023_94'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention proposed (Compartiendo Salud) is a multicomponent intervention based on prevention and on promoting the health of older adults that live alone. Quasi-experimental study was designed with pre- and post- intervention (at three months) measurements, with no Control Group or randomisation.', 'interventionNames': ['Behavioral: Compartiendo Salud']}], 'interventions': [{'name': 'Compartiendo Salud', 'type': 'BEHAVIORAL', 'description': 'The intervention proposed (Compartiendo Salud) is a multicomponent intervention based on prevention and on promoting the health of older adults that live alone. The community-based intervention consists in five workshops that are carried out during a week (one day for each workshop). The sessions (which last 2.5 hours each) are designed in an expository and participatory way, using gaming dynamics that foster learning and social interaction. The content of the workshops is the same for all BHDs. Each workshop addresses risk factors that predispose the population to experiencing more unwanted loneliness and social isolation. The concepts corresponding to each of the five sessions that comprise the intervention are: Sleep hygiene, Healthy and sustainable eating habits, Physical activity and exercise, Memory and music therapy, Digital literacy', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Cruz de La Palma', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Martín Rodríguez-Álvaro, PhD', 'role': 'CONTACT', 'email': 'mrodrigu@ull.edu.es'}], 'facility': 'La Palma Health Area. Canary Islands Health Service.', 'geoPoint': {'lat': 28.68351, 'lon': -17.76421}}], 'centralContacts': [{'name': 'Alba Francisco-Sánchez, Nursing Specialist', 'role': 'CONTACT', 'email': 'afrasanb@gobiernodecanarias.org', 'phone': '34922479460'}, {'name': 'Martín Rodríguez-Álvaro, PhD', 'role': 'CONTACT', 'email': 'mrodrigu@ull.edu.es', 'phone': '34922479460'}], 'overallOfficials': [{'name': 'Alba Francisco-Sánchez, Nursing Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atención Primaria. Área de Salud de La Palma. Servicio Canario de Salud'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': "The complete IPD will be available for sharing six months after the study's conclusion.", 'ipdSharing': 'YES', 'description': 'Data will be available upon reasonable request. The data to be shared will include all IPD that underlie results in a publication, as well as the statistical analysis plan, informed consent form and the analytic code.\n\nAll sensitive data will be anonymized to ensure the privacy and confidentiality of the participants.', 'accessCriteria': 'As an access criterion for Individual Participant Data (IPD), it is required that no information be requested that could compromise the anonymity of participants. This ensures adherence to ethical research standards and the protection of personal data, safeguarding the confidentiality and privacy of all individuals involved.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Servicio Canario de Salud', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of La Laguna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}