Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT05273502
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2022-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Earlier Elderly People in Rural Areas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is an educational program, so that, the intervention group will know that will receive some educational and behavioral activities, and the control group will know that they will not receive any kind of activities.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial (cluster)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Age in years'}, {'measure': 'Gender', 'timeFrame': 'Baseline', 'description': 'Female or male'}], 'primaryOutcomes': [{'measure': 'Risk of sarcopenia (muscle strength)', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Change of muscle strength: \\<27kg in men and \\<16kg in women measured by a dynamometer'}, {'measure': 'Diagnosis of sarcopenia (muscle strength)', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Change of muscle strength (\\<27kg in men and \\<16kg in women measured by a dynamometer)'}, {'measure': 'Diagnosis of sarcopenia (muscle mass)', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Change of muscle mass (\\<20kg in men and \\<15kg in women measured by bioimpedance)'}, {'measure': 'Diagnosis of severe sarcopenia (muscle strength)', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Change of muscle strength (\\<27kg in men and \\<16kg in women measured by a dynamometer)'}, {'measure': 'Diagnosis of severe sarcopenia (muscle mass)', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Change of muscle mass (\\<20kg in men and \\<15kg in women measured by bioimpedance)'}, {'measure': 'Diagnosis of severe sarcopenia (muscle function)', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Change of muscle function (≤0.8 m / s)'}], 'secondaryOutcomes': [{'measure': 'Nutrition', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Food frequency questionnaire (not scale)'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'International physical activity questionnaire for elderly\n\n* Low category: non-physical activity or it is not enough to achieve moderate or high category\n* Moderate category: 3 or more days / weeks (vigorous physical activity, at least 25 minutes/day), or 5 or more (moderate physical activity, at least 30 minutes/day), or 5 or more days / weeks of a combination of walking, or moderate-vigorous physical activity (at least 600 METS).\n* High category: 7 or more days / week of a combination of walking, or moderate-vigorous physical activity (at least 3000 METS).'}, {'measure': 'Sleep behaviour', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Pittsburg questionnaire The questionnaire contains a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates severe difficulty, within their respective area. The score of the seven areas is finally added to give an overall score, which ranges from 0 to 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas.'}, {'measure': 'Risk of malnutrition', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Mini Nutritional Assessment\n\n12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition'}, {'measure': 'Weight', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Weight using a balance'}, {'measure': 'height', 'timeFrame': 'Baseline and through study completion, an average of 1 year', 'description': 'Height using a tallimeter'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Behavior', 'Sarcopenia', 'Nutrition', 'Sleep', 'Physical Activity', 'Lifestyle, Healthy']}, 'descriptionModule': {'briefSummary': 'Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. Older people living in rural areas have been severely affected by confinement, and new needs are being generated. To better understand the needs, an innovative element of this project is to involve the elderly-young people (60-74 years) from rural areas in the generation of solutions, which will make these solutions especially adapted to their needs. It also aims to study the effectiveness of a health education intervention based on participatory research, where young seniors co-create and implement the intervention among their peers, and focused on improving lifestyles, to prevent or to improve sarcopenia.\n\nThe objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in rural areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.\n\nTo achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition and sarcopenia), and conduct group interviews (focus groups) including earlier elderly people from rural areas. In addition, participants will receive the intervention co-created by themselves, and the effectiveness of the intervention created will be evaluated.', 'detailedDescription': 'Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. For the first time in history, most people can aspire to live well beyond the age of 60. On the other hand, the Covid-19 pandemic has severely affected people ≥60 years of age, and may make the welfare and health problems of this population more evident, such as unhealthy lifestyles, the risk of malnutrition, and sarcopenia (defined as loss of muscle mass, strength, and function), which leads to significant dependency and quality of life problems. In addition, older people living in rural areas have been severely affected by confinement, and new needs are being generated. To better understand the needs, an innovative element of this project is to involve the elderly-young people (60-74 years) from rural areas in the generation of solutions, which will make these solutions especially adapted to their needs. Therefore increase the adherence to the solutions created, and also the long-term sustainability of the solutions. It also aims to study the effectiveness of a health education intervention based on participatory research, where young seniors co-create and implement the intervention among their peers, and focused on improving lifestyles, to prevent or to improve sarcopenia.\n\nThe objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in rural areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.\n\nTo achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition and sarcopenia), and conduct group interviews (focus groups) including earlier elderly people from rural areas, and the sectors involved, to determine their needs, interests, and barriers to pursuing healthy lifestyles. Based on the information obtained in the diagnosis and group interviews, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment. During the co-creation process, the elderly and the sectors involved in the 4-helix (government, industry, university, and civil society) will be involved. In addition, participants will receive the intervention co-created by themselves, and the effectiveness of the intervention created will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People ≥60 years and ≤74 years,\n* That they have informed consent,\n* Living at home (living independently), Community-dwelling early-elderly\n* That they can continue the study,\n* They live in the province of Tarragona.\n\nExclusion Criteria:\n\n* Failure to comply with the inclusion criteria will be considered an exclusion criterion.'}, 'identificationModule': {'nctId': 'NCT05273502', 'briefTitle': 'Earlier Elderly People in Rural Areas', 'organization': {'class': 'OTHER', 'fullName': 'University Rovira i Virgili'}, 'officialTitle': 'Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Rural Areas', 'orgStudyIdInfo': {'id': 'Earlier-Elderly Rural People'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Citizen Science Behavioral Intervention', 'description': 'The intervention group (IG) participants will receive the whole citizen science intervention of the project, and participants will be assessed at baseline and end-of-study.', 'interventionNames': ['Behavioral: Citizen Science intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.'}], 'interventions': [{'name': 'Citizen Science intervention', 'type': 'BEHAVIORAL', 'description': 'Intervention generated by a participatory research process (co-creation) in the elderly population living in rural areas to co-create solutions to improve their lifestyles, quality of life and health.', 'armGroupLabels': ['Citizen Science Behavioral Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reus', 'state': 'Tarragona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rosa Solà, Dr', 'role': 'CONTACT', 'email': 'rosa.sola@urv.cat', 'phone': '636 944 723', 'phoneExt': '0034'}], 'facility': 'University Rovira i Virgili', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}], 'centralContacts': [{'name': 'Rosa Solà, Dr', 'role': 'CONTACT', 'email': 'rosa.sola@urv.cat', 'phone': '0034 977759369'}, {'name': 'Lucia Tarro, Dr', 'role': 'CONTACT', 'email': 'lucia.tarro@urv.cat', 'phone': '0034 977758920'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rovira i Virgili', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD. Full professor', 'investigatorFullName': 'Rosa Sola', 'investigatorAffiliation': 'University Rovira i Virgili'}}}}