protocolSection identificationModule nctId: NCT06310148, orgStudyIdInfo id: UW 24-019, briefTitle: Evaluation of the Chronic Disease Co-Care Pilot Scheme, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Health and Medical Research Fund, collaborators name: Primary Healthcare Office, Hong Kong, descriptionModule briefSummary: The Chronic Disease Co-Care (CDCC) Pilot Scheme is initiated for early screening and management of people with hypertension (HT), pre-diabetes mellitus (pre-DM) and diabetes mellitus (DM) in Hong Kong. This study will evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the Scheme.This is a 12-month cohort study among the District Health Centre (DHC) or DHC Express, healthcare providers, CDCC participants and a comparison group of 1,886 non-participants. All the person-in charge, 2 family doctors and 1 of each allied health provider from each DHC/DHC Express will be administered with the questionnaires on quality of care and costing. All CDCC participants will be included in subject characteristics, among which a convenience sample of 548 will complete a telephone survey on experience, enablement and satisfaction of the CDCC Pilot Scheme. The health outcomes of 1,886 CDCC participants and 1,886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness.Participant characteristics, enablement, compliance to the standards of care, and costing of CDCC Pilot Scheme will be summarized using descriptive statistics. Differences in the proportion of patients meeting treatment targeted for HT, pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions. The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization (WHO) threshold. This study will inform future healthcare planning and policy for manpower and resource allocation., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Hypertension, conditions: Chronic Disease, conditions: Disease Management, conditions: Primary Healthcare, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 3772, type: ESTIMATED, armsInterventionsModule interventions name: The Chronic Disease Co-Care (CDCC) Pilot Scheme, outcomesModule primaryOutcomes measure: Characteristics of the Chronic Disease Co-Care (CDCC) participants, primaryOutcomes measure: Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire, primaryOutcomes measure: Enablement of CDCC participants by the Chinese Patient Enablement Instrument, primaryOutcomes measure: Effectiveness of the CDCC Pilot Scheme on disease control for pre-diabetes mellitus (pre-DM) and DM in percent of Glycated Hemoglobin (HbA1c) and hypertension (HT) in millimeter of mercury of systolic blood pressure (SBP)/diastolic blood pressure (DBP), primaryOutcomes measure: The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire, primaryOutcomes measure: The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio, secondaryOutcomes measure: Experience and satisfaction of CDCC participants by the experience and enablement questionnaire, secondaryOutcomes measure: Number of attendance to doctor consultation on times in comparison groups, secondaryOutcomes measure: Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups, secondaryOutcomes measure: Changes in mean HbA1c/FPG in percent between two groups, secondaryOutcomes measure: Changes in mean SBP and DBP in millimeter of mercury between two groups, secondaryOutcomes measure: Changes in mean of HbA1c in percent between two groups, secondaryOutcomes measure: Changes in BMI in kilogram per square metre between two groups, secondaryOutcomes measure: Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment, secondaryOutcomes measure: The predicted 10-year cardiovascular disease (CVD) risk between two groups, secondaryOutcomes measure: Amount of direct medical costs between two groups, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Eric Yuk Fai Wan, role: CONTACT, phone: 852 28315057, phoneExt: 852 28147475, email: yfwan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False