Evaluation of the Chronic Disease Co-Care Pilot Scheme

NCT06310148 | Recruiting

• 1 other identifier: UW 24-019
• Study Type: interventional
• Target: 3,772
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Chronic Disease; Disease Management; Primary Healthcare

Outcome Measures

Primary Outcomes (6)

• Characteristics of the Chronic Disease Co-Care (CDCC) participants

  Characteristics including demographics, comorbidities, and medications of the CDCC participants. For continuous variables, age will be presented in years, blood pressure will be presented in millimeters of mercury, fasting glucose, low-density-lipoprotein cholesterol and triglycerides will be presented in millimole per liter, weight in kilograms and height in meter will be combined to report body mass index (BMI) in kg/m\^2, estimated glomerular filtration rate will be presented in milliliters per minute per 1.73m\^2. For categorical variables, frequency and proportion will be used. participants. For continuous variables, age will be presented in years. For categorical variables, frequency and proportion will be used.

  Characteristics of CDCC participants will be described at baseline

• Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire

  The standards (proportion of participants) achieved by the program in each of the criterion specified under each domain of quality of care according to the CDCC Pilot Scheme protocol. The questionnaire is developed based on the evaluation framework on structure, process and outcome. The percentage of adherence out of 100% based on pre-determined key performance indicators will be reported. A higher score means a greater adherence to the standards of care.

  Questionnaires will be implemented at 6 months and 12 months after the study begins

• Enablement of CDCC participants by the Chinese Patient Enablement Instrument

  Participants' enablement will be measured by the Chinese Patient Enablement Instrument (PEI) at 12 months following the enrolment into the CDCC Pilot Scheme

  12 months

• 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)

  Differences in the proportion of CDCC participants achieving the target outcome of disease control after 12 months as compared with non-CDCC participants. Target outcomes of disease control are defined as below: * Pre-DM: Reduction in HbA1c * HT: SBP/DBP \< 140/90 millimetres of mercury (mmHg) * DM: HbA1c \< 7%

  12 months

• The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire

  The additional costs incurred on the CDCC Pilot Scheme from healthcare providers' perspective estimated from the manpower and pay scale of staff reported in the questionnaire, as well as the cost for acquiring physical space, equipment, and other IT infrastructure needed for the program. Costs will be presented as absolute values (HKD and USD).

  12 months

• The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio

  The incremental cost-effectiveness ratio (ICER) per individual achieving the target outcome of disease control for the CDCC Pilot Scheme compared to the cost-effectiveness threshold of 1 annual Gross Domestic Product (GDP) after 12 months

  12 months

Secondary Outcomes (10)

• Experience and satisfaction of CDCC participants by the experience and enablement questionnaire

  Experience and satisfaction of CDCC participants will be evaluated at 3 months and 12 months after recruitment

• Number of attendance to doctor consultation on times in comparison groups

  12 months

• Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups

  12 months

• Changes in mean HbA1c/FPG in percent between two groups

  12 months

• Changes in mean SBP and DBP in millimeter of mercury between two groups

  12 months

Study Arms (2)

Participating in Chronic Disease Co-Care Pilot Scheme

EXPERIMENTAL

Participants will receive comprehensive health management plans and necessary medication treatment from family doctors, based on their clinical condition. Nurse clinic will provide disease prevention education, health assessment, and counselling services, whereas allied health professionals (including optometrists, podiatrists, dietitians, and physiotherapists) will provide individualized intervention services for participants.

Combination Product: The Chronic Disease Co-Care (CDCC) Pilot Scheme

Not participating in Chronic Disease Co-Care Pilot Scheme

NO INTERVENTION

Eligible non-CDCC participants will only be referred to the laboratories of a designated service provider by the research team for physical examination, blood tests, and urine test as a screening for DM and HT. No health management plans and necessary medication treatment would be provided to them in this study.

Interventions

The Chronic Disease Co-Care (CDCC) Pilot Scheme COMBINATION_PRODUCT

Participants will receive comprehensive health management plans and necessary medication treatment from family doctors, based on their clinical condition. Nurse clinic will provide disease prevention education, health assessment, and counselling services, whereas allied health professionals (including optometrists, podiatrists, dietitians, and physiotherapists) will provide individualized intervention services for participants.

Participating in Chronic Disease Co-Care Pilot Scheme

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hong Kong residents
• Aged ≥45 years
• Registered as a member of DHC/DHC Express
• Provided informed consent on sharing their data in the electronic Health Record Sharing System
• Provided consent to join the CDCC Pilot Scheme Terms and Conditions.

You may not qualify if:

• With known history of DM or HT
• Hong Kong residents
• Aged ≥45 years
• Provided informed consent for the study.
• Without known history of DM or HT

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator
• Primary Healthcare Office, Hong Kong: collaborator

Study Sites (1)

Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Mak IL, Liu KSN, Wong ZCT, Xu VYH, Yu EYT, Ha TKH, Wong WCW, Tse ETY, Chan L, Ng APP, Choi EPH, Roland M, Bishai D, Lam CLK, Wan EYF. Evaluation of the effectiveness and cost-effectiveness of the chronic disease co-care (CDCC) Pilot Scheme: a study protocol. BMC Prim Care. 2025 Mar 19;26(1):73. doi: 10.1186/s12875-025-02765-6.

  PMID: 40108515 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eric Yuk Fai Wan

CONTACT

852 2831 5057; yfwan@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: March 15, 2024
• Study Start: January 18, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)