Diabetes Mellitus, Type 2NCT06310148
Evaluation of the Chronic Disease Co-Care Pilot Scheme
A study testing The Chronic Disease Co-Care (CDCC) Pilot Scheme in people with Diabetes Mellitus, Type 2 and Hypertension, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension, Chronic Disease
- What is being tested?
- The Chronic Disease Co-Care (CDCC) Pilot Scheme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,772 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Hong Kong residents
- Aged ≥45 years
- Provided informed consent for the study.
Who cannot join
- With known history of DM or HT
- Without known history of DM or HT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG
Hong Kong
Eric Yuk Fai Wan, 852 28315057 ext. 852 28147475, yfwan@hku.hk
About this study
Official title: An Evaluation of the Effectiveness and Cost-effectiveness of the Chronic Disease Co-Care (CDCC) Pilot Scheme: a Commissioned Study
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.
Read the detailed description
This study aims to evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the CDCC Pilot Scheme in Hong Kong. The objectives of this study are the following:
- Describe the characteristics of participants of the CDCC Pilot Scheme;
- Measure the standards of adherence to care criteria achieved by healthcare providers participating in the CDCC Pilot Scheme;
- Evaluate participant acceptability by self-reported outcomes on enablement, experience and satisfaction level about the services of CDCC;
- Evaluate the effectiveness of the CDCC Pilot Scheme on improving health outcomes among CDCC participants over 12 months;
- Determine the provider costs and cost-effectiveness for delivering the CDCC Pilot Scheme relative to its effectiveness on participants health outcomes
The detailed study design of each objective are:
Objective (a): All participants in CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included in the evaluation. The characteristics including demographics, comorbidities, and medications of the participants will be summarized using descriptive statistics.
Objective (b): For the evaluation of the structure of care, quantitative data will be collected through structured questionnaires on the quality of care with DHC/DHC Express managers at 6 months and repeated at 12 months. Each DHC/DHC Express will also nominate two family doctors and one of each network allied health professionals (optometrists, podiatrists, dietitians, and physiotherapists subject to the availability in each center) within their service network to complete the questionnaire at 12 months. For the evaluation of the standards on process and outcome of care, all participants in the CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included.
Objective (c): Participants will be conveniently sampled after completion of the Health Risk Factor Assessment (HRFA) at DHC/DHC Express between 1 Jan 2024 and 31 Mar 2024 to complete surveys on self-reported outcomes. For the first survey at 3 months, a questionnaire will be used to assess participants' enablement level and experience during the screening phase. The second follow-up survey will be administered at 12 months to assess participants' experience in clinical encounters.
Objective (d): This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the effectiveness of the CDCC Pilot Scheme. A total of 264 CDCC participants, and 264 non-CDCC participants screened positive for HT, pre-DM, or DM will be included as intervention and comparison group, respectively. All participants will be followed up 12 months. Records for CDCC participants who meet the inclusion criteria between 1 Jan 2024 and 30 Apr 2024, will be extracted from the Electronic Health Record Sharing System database. Meanwhile, a convenient sample of 1,886 non-CDCC participants (comparison group) will be recruited from the community between 1 Jan 2024 and 30 Apr 2024.
Objective (e): This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the costs and cost-effectiveness of the CDCC Pilot Scheme. The total costs incurred on the CDCC Pilot Scheme from 1st January 2024 to 31st December 2024, including set-up costs, ongoing operational costs and ongoing administrative and maintenance costs will be collected via questionnaires. Direct medical costs for CDCC participants and non-CDCC participants will be collected after 12 months.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension, Chronic Disease, Disease Management, Primary Healthcare
- Being tested
- The Chronic Disease Co-Care (CDCC) Pilot Scheme
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Chronic Disease Co-Care (CDCC) Pilot SchemeCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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%
Measured: 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).
Measured: 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
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 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
Self-reported attendance to doctor consultation over the past 12 months for patients in comparison groups.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Changes in mean SBP and DBP in millimeter of mercury between two groups
Differences in the changes in mean SBP and DBP from baseline to 12 months between hypertension patients enrolled in the CDCC Pilot Scheme and comparison group.
Measured: 12 months
Changes in mean of HbA1c in percent between two groups
Differences in the changes in mean of HbA1c from baseline to 12 months between DM patients enrolled in the CDCC Pilot Scheme and comparison group.
Measured: 12 months
Changes in BMI in kilogram per square metre between two groups
Differences in BMI from baseline to 12 months between patients enrolled in the CDCC Pilot Scheme compared to comparison group.
Measured: 12 months
Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment
Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment
Measured: 12 months
The predicted 10-year cardiovascular disease (CVD) risk between two groups
Differences in the predicted 10-year CVD risk using Framingham Risk Score and local CVD risk prediction model between patients enrolled in the CDCC Pilot Scheme compared to comparison group. The Framingham Risk Score ranges from 0% to 100% where higher scores indicate poorer outcomes.
Measured: 12 months
Amount of direct medical costs between two groups
The direct medical costs of CDCC participants as compared with non-CDCC participants
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start18 Jan 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund, Primary Healthcare Office, Hong Kong
- Responsible party
- Principal investigator, Dr. Eric Yuk Fai Wan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310148
- Sponsor's protocol ID
- UW 24-019
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40108515
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness and Cost-effectiveness of the Chronic Disease Co-Care (CDCC) Pilot Scheme: a Commissioned Study
- ClinicalTrials.gov ID
- NCT06310148
- Acronym / sponsor ID
- UW 24-019
- Conditions
- Diabetes Mellitus, Type 2, Hypertension, Chronic Disease, Disease Management, Primary Healthcare
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,772 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund, Primary Healthcare Office, Hong Kong
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the CDCC Pilot Scheme in Hong Kong. The objectives of this study are the following:
- Describe the characteristics of participants of the CDCC Pilot Scheme;
- Measure the standards of adherence to care criteria achieved by healthcare providers participating in the CDCC Pilot Scheme;
- Evaluate participant acceptability by self-reported outcomes on enablement, experience and satisfaction level about the services of CDCC;
- Evaluate the effectiveness of the CDCC Pilot Scheme on improving health outcomes among CDCC participants over 12 months;
- Determine the provider costs and cost-effectiveness for delivering the CDCC Pilot Scheme relative to its effectiveness on participants health outcomes
The detailed study design of each objective are:
Objective (a): All participants in CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included in the evaluation. The characteristics including demographics, comorbidities, and medications of the participants will be summarized using descriptive statistics.
Objective (b): For the evaluation of the structure of care, quantitative data will be collected through structured questionnaires on the quality of care with DHC/DHC Express managers at 6 months and repeated at 12 months. Each DHC/DHC Express will also nominate two family doctors and one of each network allied health professionals (optometrists, podiatrists, dietitians, and physiotherapists subject to the availability in each center) within their service network to complete the questionnaire at 12 months. For the evaluation of the standards on process and outcome of care, all participants in the CDCC Pilot Scheme between 1 Jan 2024 and 30 Jun 2024 will be included.
Objective (c): Participants will be conveniently sampled after completion of the Health Risk Factor Assessment (HRFA) at DHC/DHC Express between 1 Jan 2024 and 31 Mar 2024 to complete surveys on self-reported outcomes. For the first survey at 3 months, a questionnaire will be used to assess participants' enablement level and experience during the screening phase. The second follow-up survey will be administered at 12 months to assess participants' experience in clinical encounters.
Objective (d): This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the effectiveness of the CDCC Pilot Scheme. A total of 264 CDCC participants, and 264 non-CDCC participants screened positive for HT, pre-DM, or DM will be included as intervention and comparison group, respectively. All participants will be followed up 12 months. Records for CDCC participants who meet the inclusion criteria between 1 Jan 2024 and 30 Apr 2024, will be extracted from the Electronic Health Record Sharing System database. Meanwhile, a convenient sample of 1,886 non-CDCC participants (comparison group) will be recruited from the community between 1 Jan 2024 and 30 Apr 2024.
Objective (e): This will be a 1-year comparative cohort study including CDCC and non-CDCC participants to evaluate the costs and cost-effectiveness of the CDCC Pilot Scheme. The total costs incurred on the CDCC Pilot Scheme from 1st January 2024 to 31st December 2024, including set-up costs, ongoing operational costs and ongoing administrative and maintenance costs will be collected via questionnaires. Direct medical costs for CDCC participants and non-CDCC participants will be collected after 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participating in Chronic Disease Co-Care Pilot Scheme | Experimental | Combination Product: The Chronic Disease Co-Care (CDCC) Pilot SchemeParticipants 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. |
| 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- With known history of DM or HT
- Without known history of DM or HT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Chronic Disease Co-Care (CDCC) Pilot SchemeParticipants 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 | Participating in Chronic Disease Co-Care Pilot Scheme |
Primary outcome
Characteristics of the Chronic Disease Co-Care (CDCC) participants
Time frame: Characteristics of CDCC participants will be described at baseline
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.
Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire
Time frame: Questionnaires will be implemented at 6 months and 12 months after the study begins
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.
Enablement of CDCC participants by the Chinese Patient Enablement Instrument
Time frame: 12 months
Participants' enablement will be measured by the Chinese Patient Enablement Instrument (PEI) at 12 months following the enrolment into the CDCC Pilot Scheme
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)
Time frame: 12 months
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%
The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire
Time frame: 12 months
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).
The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio
Time frame: 12 months
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
10 secondary outcomes
Experience and satisfaction of CDCC participants by the experience and enablement questionnaire
Time frame: 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
Time frame: 12 months
Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups
Time frame: 12 months
Changes in mean HbA1c/FPG in percent between two groups
Time frame: 12 months
Changes in mean SBP and DBP in millimeter of mercury between two groups
Time frame: 12 months
Changes in mean of HbA1c in percent between two groups
Time frame: 12 months
Changes in BMI in kilogram per square metre between two groups
Time frame: 12 months
Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment
Time frame: 12 months
The predicted 10-year cardiovascular disease (CVD) risk between two groups
Time frame: 12 months
Amount of direct medical costs between two groups
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 40108515Mak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Chronic Disease Co-Care (CDCC) Pilot Scheme in people with Diabetes Mellitus, Type 2 and Hypertension, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Yuk Fai Wan (852 2831 5057, yfwan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of the Chronic Disease Co-Care (CDCC) participants (time frame: Characteristics of CDCC participants will be described at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06310148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.