Evaluation of the Chronic Disease Co-Care Pilot Scheme

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

With known history of DM or HT

Hong Kong residents

Aged ≥45 years

Provided informed consent for the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

3,772 Participants
are divided into 2 treatment groups
Group A: Participating in Chronic Disease Co-Care Pilot SchemeExperimental treatment 1 intervention
Group B: Not participating in Chronic Disease Co-Care Pilot SchemeNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Characteristics of CDCC participants will be described at baseline
2

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.

Time frame
Questionnaires will be implemented at 6 months and 12 months after the study begins
3

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

Time frame
12 months
4

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%

Time frame
12 months

Secondary outcomes

1

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

Participants' experience and satisfaction of services provided by the CDCC Pilot Scheme will be measured by self-reported experience and enablement questionnaire. It includes the standardized Patient Enablement Index with a total score ranging from 0 to 12, where higher scores indicate a better outcome. Other items were developed and adapted based on similar questionnaires. Patient experience and satisfaction levels will be assessed on a 4-point Likert scale with a higher score suggesting better satisfaction / experience.

Time frame
Experience and satisfaction of CDCC participants will be evaluated at 3 months and 12 months after recruitment
2

Number of attendance to doctor consultation on times in comparison groups

Self-reported attendance to doctor consultation over the past 12 months for patients in comparison groups.

Time frame
12 months
3

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

Self-reported diagnosis of HT and/or DM on dichotomous yes/no response over the past 12 months for patients in comparison groups.

Time frame
12 months
4

Changes in mean HbA1c/FPG in percent between two groups

Differences in the changes in mean HbA1c/fasting plasma glucose (FPG) from baseline to 12 months between pre-DM patients enrolled in the CDCC Pilot Scheme compared to comparison group.

Time frame
12 months

Other outcomes

Sponsors and contacts

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The University of Hong Kong

Lead sponsor

Health and Medical Research Fund

Collaborator

Primary Healthcare Office, Hong Kong

Collaborator