protocolSection identificationModule nctId: NCT06313138, orgStudyIdInfo id: NantongJS, briefTitle: Effectiveness of Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2023-12-25, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nantong University, class: OTHER, collaborators name: Chiang Mai University, descriptionModule briefSummary: The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity.Specific objectives are:1. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between before and after receiving the individual and family health literacy enhancement program.2. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between those receiving the individual and family health literacy enhancement program and those receiving usual care.Participants in the control group will receive usual care by physician and nurses during the experimental period. The usual care consists of physical examination, regular treatment protocol, patient education and telephone follow-up by community nurses.Participants in the interventional group will receive the program which is a group-based intervention developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.The program will be divided into 8 sessions. Each session will be lasted for 2 hours with 1 intermittent break (10 minutes), and it will be held twice a week, and the last session will be held 1 week after the 7th session. Therefore, it will last for 5 weeks in total., conditionsModule conditions: Multiple Chronic Conditions；Diabetes；Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: The Individual and Family Enhancement Program, outcomesModule primaryOutcomes measure: Self-management, primaryOutcomes measure: Treatment burden, primaryOutcomes measure: Symptom burden, secondaryOutcomes measure: Health literacy, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantong University, city: Nantong, state: Jiang Su, zip: 226001, country: China, geoPoint lat: 32.03028, lon: 120.87472, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-11-17, uploadDate: 2024-03-08T04:09, filename: ICF_000.pdf, size: 3095464, hasResults: False