HypertensionTRACCNCT04302974
Cohort Study on Patient Outcomes, Effectiveness and Cost-effectiveness of Intervention Programmes for DM/HT Patients
An observational study of Hypertension and Diabetes Mellitus, run by The University of Hong Kong at 1 site in China.
Trial summary
Objectives: To determine the outcome trajectories of patients with hypertension (HT) and/or diabetes mellitus (DM), and evaluate the long-term effectiveness and cost-effectiveness of the Risk Assessment and Management Programmes (RAMP) and other primary care services such as Patient Support Call Centre (PSCC) on… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Different structures and processes of primary care management strategies, Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM) and Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT)
- Type of treatment
- Surgery or procedure
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: * All Chinese patients aged 18 years or above with a documented doctor-diagnosed DM or HT between 2006 and 2021. * Documented management in the HA GOPC or FMC identified from the HA CM database between 2006 and 2021.
Who may be able to join
- (Trajectory study)
- All patients aged 18 years or above with a documented doctor-diagnosed DM or HT between 2006 and 2019.
- Documented management in the HA GOPC or FMC identified from the HA CM database between 2006 and 2019.
- (10-year CEA study on RAMP-DM)
- Documented diagnosis of DM without any known complications on or before September 2010
- Documented management in the HA GOPC and FMC identified from the HA CMS database between 2009 and 2019,
Show all 19Show fewer
- Patients who attended the first RAMP-DM assessment between August 2009 to September 2010 for inclusion in the RAMP-DM cohort
- Patients who have never attended any RAMP-DM assessment between August 2009 to December 2019 for inclusion in the usual care only cohort
- (10-year CEA study on RAMP-HT)
- Documented diagnosis of HT without DM and any known complications on or before March 2013
- Documented management in the HA GOPC and FMC identified from the HA CMS database between 2011 and 2021,
- Patients who attended the first RAMP-HT assessment between October 2011 to March 2013 for inclusion in the RAMP-HT cohort
- Patients who have never attended any RAMP-HT assessment between October 2011 to December 2021 for inclusion in the usual care only cohort
- (5-year CEA study on PSCC)
- Documented diagnosis of DM without any known complications on or before August 2016
- Documented management in the HA GOPC and FMC identified from the HA CMS database between 2012 and 2021,
- Patients who attended the first RAMP-DM assessment between September 2012 to August 2016
- Patients who received the first PSCC call between September 2012 to August 2016 after the first RAMP-DM assessment for inclusion in the PSCC cohort
- Patients who have never received any PSCC services between September 2012 to December 2021 for inclusion in the RAMP only cohort
Who cannot join
- (applicable to all sub-studies)
- Non-Chinese
- Patients with documented DM/HT-related complications diagnosed before the date of enrolment
- Medical specialist outpatient attendance before or within the first year of inclusion to study, to exclude subjects who might have developed complications before study enrolment
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Family Medicine & Primary Care, LKS Faculty of Medicine, University of Hong Kong
Hong Kong, Hong Kong
About this study
Official title: Cohort Study to Investigate the Outcomes of Patients With Hypertension and/or Diabetes Mellitus and the Effectiveness and Cost-effectiveness of Structured Multi-disciplinary Intervention Programmes
Objectives: To determine the outcome trajectories of patients with hypertension (HT) and/or diabetes mellitus (DM), and evaluate the long-term effectiveness and cost-effectiveness of the Risk Assessment and Management Programmes (RAMP) and other primary care services such as Patient Support Call Centre (PSCC) on reducing complications and mortality
Design: Population-based cohort study
Read more
Setting: Hospital Authority (HA) primary care clinics Participants: All patients aged ≥18 years with DM or HT managed in HA primary care clinics between 2006 and 2021
Main outcome measures: (1) incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality); (2) service utilization (out-patient clinics, Accident and Emergency and overnight hospitalizations); (3) Incremental cost-effectiveness ratio per complications or all-cause death avoided, and per QALY gained by RAMP or PSCC.
Methods: A naturalistic cohort study (maximum 10-year follow-up) and retrospective data extraction from the HA clinical management system (CMS) database will be conducted to identify and correlate outcome trajectories of HT and/or DM patients with personal, service delivery and process of care factors. Outcomes of propensity score matched cohorts who have and have not participated in the programmes will be compared. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression will be conducted to evaluate the effect of RAMP, PSCC and other primary care services on the risk of complications, mortality and service utilization. Empirical costs and effectiveness data will be used to calculate cost-effectiveness from the provider's perspective.
Significance: Findings will inform how to optimize service delivery for HT/DM patients in Hong Kong
Read the detailed description
A naturalistic cohort study with a maximum follow-up period of 10 years, and retrospective extraction of relevant data from the HA clinical management system (CMS) database, designed as four sub-studies:-
- A trajectory study on all HA primary care patients with HT and/or DM receiving care from 2006 to 2019, to explore the trajectory patterns for clinical, treatment and complication profiles and investigate the impact of multi-morbidity, continuity-of-care, different service delivery models and management strategies (including investigation frequency and specific drug regimens) on outcomes and health service utilization.
- A 10-year effectiveness and cost-effectiveness analysis (CEA) of RAMP-DM. A cohort of RAMP-DM patients will be compared against a propensity score matched cohort of 'usual care' only DM patients to determine the effectiveness and cost-effectiveness of RAMP-DM on reducing complications and mortality and gain in quality adjusted life years (QALY). The optimal criteria and frequency of repeating RAMP-DM will be determined.
- A 10-year effectiveness and CEA of RAMP-HT. A cohort of RAMP-HT will be compared against a propensity score matched cohort of 'usual care' only HT patients to determine the effectiveness and cost-effectiveness of RAMP-HT on reducing complications and mortality and gain in QALY. The optimal criteria and frequency of repeating RAMP-HT will be determined
- An evaluation on the effectiveness and cost-effectiveness of PSCC. A cohort of RAMP-DM plus PSCC (RAMP-DM+PSCC) will be compared against a propensity score matched cohort of RAMP-DM only patients to evaluate the effectiveness and cost effectiveness of PSCC on the reduction of complications and mortality and gain in QALY.
- Conditions
- Hypertension, Diabetes Mellitus, Cardiovascular Diseases, Morbidity, Multiple, Kidney Disease, Chronic, Death
- Being tested
- Different structures and processes of primary care management strategies, Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM), Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT), Patient Support Call Centre (PSCC)
- Keywords
- Continuity of care, Multi-morbidity, Effectiveness, Cost-effectiveness, Multi-disciplinary intervention programme
- Medical subject headings
- Hypertension, Diabetes Mellitus, Cardiovascular Diseases, Renal Insufficiency, Chronic, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different structures and processes of primary care management strategiesProcedure or surgery
Different structures and processes of primary care management strategies includes: Multi-morbidity, continuity-of-care, different service delivery models and management strategies (i.e. investigation frequency and specific drug regimens)
Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM)Procedure or surgery
Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for diabetes (RAMP-DM), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All DM patients are eligible to enrol into the DM RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor.
Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT)Procedure or surgery
Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for hypertension (RAMP-HT), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All HT patients are eligible to enrol into the HT RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor.
Patient Support Call Centre (PSCC)Procedure or surgery
RAMP Patients can also be referred to the Patient Empowerment Programme(PEP) - a structured self-care education programme delivered by non-governmental organisations(NGOs). If the DM control is suboptimal but the patient is unable to attend the PEP, they may be referred to the Patient Support Call Centre(PSCC) service. PSCC provides individualized telephone counselling by trained nurses. PSCC empowers high-risk DM patients to engage in self-care behaviours by providing regular protocol-led telephone support to advise and reinforce healthy behaviours. Targeted self-care behaviours include self-monitoring, medication management, balanced diet, exercise, risk factor reduction, problem solving and healthy coping. Enrolled patients receive weekly to bi-weekly calls in the first 3 months and additional calls as required for a maximum of 9 months. Subsequent follow-up calls are undertaken to assess self-care behaviours related to the selected goals and to develop a care plan with the patient.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1: Trajectory study | All HA primary care patients aged 18 years or above with doctor-documented HT and/or DM receiving care in HA General Out-patient Clinics or Family Medicine Clinics (FMC) identified from the HA CMS database between 2006 and 2019, to explore the trajectory patterns for clinical, treatment and complication profiles and investigate the impact of multi-morbidity, continuity-of-care, different service delivery models and management strategies (including investigation frequency and specific drug regimens) on outcomes and health service utilization. Receives: Procedure: Different structures and processes of primary care management strategies | |
| Sub-study 2: RAMP-DM | A cohort of patients with i) diagnosis of DM without any known complications on or before September 2010 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2009 and 2019, who attended the first RAMP-DM assessment between August 2009 to September 2010 Receives: Procedure: Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM) | |
| Sub-study 2: usual care only | A cohort of patients with i) diagnosis of DM without any known complications on or before September 2010 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2009 and 2019, who have never attended any RAMP-DM assessment between August, 2009 to December, 2019 | |
| Sub-study 3: RAMP-HT | A cohort of patients with i) diagnosis of HT without DM and any known complications on or before March 2013 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2011 and 2021, who attended the first RAMP-HT assessment between October 2011 to March 2013 Receives: Procedure: Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT) | |
| Sub-study 3: usual care only | A cohort of patients with i) diagnosis of HT without DM and any known complications on or before March 2013 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2011 and 2021, who have never attended any RAMP-HT assessment between October 2011 to December 2021 | |
| Sub-study 4: PSCC | A cohort of patients with i) diagnosis of DM without any known complications on or before August 2016, ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2012 and 2021 iii) attended the first RAMP-DM assessment between September, 2012 to August, 2016, who have received the first PSCC call between September, 2012 to August, 2016 after the first RAMP-DM assessment Receives: Procedure: Patient Support Call Centre (PSCC) | |
| Sub-study 4: without PSCC | A cohort of patients with i) diagnosis of DM without any known complications on or before August 2016, ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2012 and 2021 iii) attended the first RAMP-DM assessment between September, 2012 to August, 2016, who have never received any PSCC services between September 2012 to December 2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality)
The disease are defined by the diagnosis codes International Classification of Primary Care, Second edition or International Classification of Diseases,Ninth Revision, Clinical Modification.
Measured: 10 years
Service utilization rate (out-patient clinics, Accident and Emergency and hospitalizations)
Based on the electronic health record from Hong Kong Hospital Authority
Measured: 10 years
Incremental cost-effectiveness ratio per DM/HT-related complication or all-cause death avoided, and per QALY gained by RAMP or PSCC
The incremental cost-effectiveness ratio (ICER), that is the ratio of the incremental costs of the RAMP group over the incremental effectiveness, will be calculated for each complication event, or death avoided, and per QALY gain.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Aug 2019
- Primary completion30 Jun 2024
- Study completion30 Sep 2024
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 HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Cindy L.K. Lam, The University of Hong Kong
- Investigators
- Cindy L.K. Lam, MD, Principal investigator, Professor and Head of Department of Family Medicine & Primary Care, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302974
- Sponsor's protocol ID
- UW19-329
- Acronym
- TRACC
- Status last verified
- Dec 2024
- First submitted
- 3 Mar 2020
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wan EYF, Chin WY, Yu EYT, Chen J, Tse ETY, Wong CKH, Ha TKH, Chao DVK, Tsui WWS, Lam CLK. Retrospective cohort study to investigate the 10-year trajectories of disease patterns in patients with hypertension and/or diabetes mellitus on subsequent cardiovascular outcomes and health service utilisation: a study protocol. BMJ Open. 2021 Feb 5;11(2):e038775. doi: 10.1136/bmjopen-2020-038775.
PubMed 33550225
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Investigate the Outcomes of Patients With Hypertension and/or Diabetes Mellitus and the Effectiveness and Cost-effectiveness of Structured Multi-disciplinary Intervention Programmes
- ClinicalTrials.gov ID
- NCT04302974
- Acronym / sponsor ID
- TRACC / UW19-329
- Conditions
- Hypertension, Diabetes Mellitus, Cardiovascular Diseases, Morbidity, Multiple, Kidney Disease, Chronic, Death
- Keywords
- Continuity of care, Multi-morbidity, Effectiveness, Cost-effectiveness, Multi-disciplinary intervention programme
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Mar 2020 (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.
Objectives: To determine the outcome trajectories of patients with hypertension (HT) and/or diabetes mellitus (DM), and evaluate the long-term effectiveness and cost-effectiveness of the Risk Assessment and Management Programmes (RAMP) and other primary care services such as Patient Support Call Centre (PSCC) on reducing complications and mortality
Design: Population-based cohort study
Setting: Hospital Authority (HA) primary care clinics Participants: All patients aged ≥18 years with DM or HT managed in HA primary care clinics between 2006 and 2021
Main outcome measures: (1) incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality); (2) service utilization (out-patient clinics, Accident and Emergency and overnight hospitalizations); (3) Incremental cost-effectiveness ratio per complications or all-cause death avoided, and per QALY gained by RAMP or PSCC.
Methods: A naturalistic cohort study (maximum 10-year follow-up) and retrospective data extraction from the HA clinical management system (CMS) database will be conducted to identify and correlate outcome trajectories of HT and/or DM patients with personal, service delivery and process of care factors. Outcomes of propensity score matched cohorts who have and have not participated in the programmes will be compared. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression will be conducted to evaluate the effect of RAMP, PSCC and other primary care services on the risk of complications, mortality and service utilization. Empirical costs and effectiveness data will be used to calculate cost-effectiveness from the provider's perspective.
Significance: Findings will inform how to optimize service delivery for HT/DM patients in Hong Kong
Detailed description
A naturalistic cohort study with a maximum follow-up period of 10 years, and retrospective extraction of relevant data from the HA clinical management system (CMS) database, designed as four sub-studies:-
- A trajectory study on all HA primary care patients with HT and/or DM receiving care from 2006 to 2019, to explore the trajectory patterns for clinical, treatment and complication profiles and investigate the impact of multi-morbidity, continuity-of-care, different service delivery models and management strategies (including investigation frequency and specific drug regimens) on outcomes and health service utilization.
- A 10-year effectiveness and cost-effectiveness analysis (CEA) of RAMP-DM. A cohort of RAMP-DM patients will be compared against a propensity score matched cohort of 'usual care' only DM patients to determine the effectiveness and cost-effectiveness of RAMP-DM on reducing complications and mortality and gain in quality adjusted life years (QALY). The optimal criteria and frequency of repeating RAMP-DM will be determined.
- A 10-year effectiveness and CEA of RAMP-HT. A cohort of RAMP-HT will be compared against a propensity score matched cohort of 'usual care' only HT patients to determine the effectiveness and cost-effectiveness of RAMP-HT on reducing complications and mortality and gain in QALY. The optimal criteria and frequency of repeating RAMP-HT will be determined
- An evaluation on the effectiveness and cost-effectiveness of PSCC. A cohort of RAMP-DM plus PSCC (RAMP-DM+PSCC) will be compared against a propensity score matched cohort of RAMP-DM only patients to evaluate the effectiveness and cost effectiveness of PSCC on the reduction of complications and mortality and gain in QALY.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1: Trajectory study | – | Procedure: Different structures and processes of primary care management strategiesAll HA primary care patients aged 18 years or above with doctor-documented HT and/or DM receiving care in HA General Out-patient Clinics or Family Medicine Clinics (FMC) identified from the HA CMS database between 2006 and 2019, to explore the trajectory patterns for clinical, treatment and complication profiles and investigate the impact of multi-morbidity, continuity-of-care, different service delivery models and management strategies (including investigation frequency and specific drug regimens) on outcomes and health service utilization. |
| Sub-study 2: RAMP-DM | – | Procedure: Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM)A cohort of patients with i) diagnosis of DM without any known complications on or before September 2010 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2009 and 2019, who attended the first RAMP-DM assessment between August 2009 to September 2010 |
| Sub-study 2: usual care only | – | –A cohort of patients with i) diagnosis of DM without any known complications on or before September 2010 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2009 and 2019, who have never attended any RAMP-DM assessment between August, 2009 to December, 2019 |
| Sub-study 3: RAMP-HT | – | Procedure: Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT)A cohort of patients with i) diagnosis of HT without DM and any known complications on or before March 2013 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2011 and 2021, who attended the first RAMP-HT assessment between October 2011 to March 2013 |
| Sub-study 3: usual care only | – | –A cohort of patients with i) diagnosis of HT without DM and any known complications on or before March 2013 and ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2011 and 2021, who have never attended any RAMP-HT assessment between October 2011 to December 2021 |
| Sub-study 4: PSCC | – | Procedure: Patient Support Call Centre (PSCC)A cohort of patients with i) diagnosis of DM without any known complications on or before August 2016, ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2012 and 2021 iii) attended the first RAMP-DM assessment between September, 2012 to August, 2016, who have received the first PSCC call between September, 2012 to August, 2016 after the first RAMP-DM assessment |
| Sub-study 4: without PSCC | – | –A cohort of patients with i) diagnosis of DM without any known complications on or before August 2016, ii) Documented management in the HA General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) identified from the HA CMS database between 2012 and 2021 iii) attended the first RAMP-DM assessment between September, 2012 to August, 2016, who have never received any PSCC services between September 2012 to December 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * All Chinese patients aged 18 years or above with a documented doctor-diagnosed DM or HT between 2006 and 2021. * Documented management in the HA GOPC or FMC identified from the HA CM database between 2006 and 2021.
Key inclusion criteria (19 listed)
- (Trajectory study)
- All patients aged 18 years or above with a documented doctor-diagnosed DM or HT between 2006 and 2019.
- Documented management in the HA GOPC or FMC identified from the HA CM database between 2006 and 2019.
- (10-year CEA study on RAMP-DM)
- Documented diagnosis of DM without any known complications on or before September 2010
Key exclusion criteria (4 listed)
- (applicable to all sub-studies)
- Non-Chinese
- Patients with documented DM/HT-related complications diagnosed before the date of enrolment
- Medical specialist outpatient attendance before or within the first year of inclusion to study, to exclude subjects who might have developed complications before study enrolment
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 |
|---|---|---|
| Different structures and processes of primary care management strategiesDifferent structures and processes of primary care management strategies includes: Multi-morbidity, continuity-of-care, different service delivery models and management strategies (i.e. investigation frequency and specific drug regimens) | Procedure or surgery | Sub-study 1: Trajectory study |
| Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM)Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for diabetes (RAMP-DM), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All DM patients are eligible to enrol into the DM RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor. | Procedure or surgery | Sub-study 2: RAMP-DM |
| Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT)Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for hypertension (RAMP-HT), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All HT patients are eligible to enrol into the HT RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor. | Procedure or surgery | Sub-study 3: RAMP-HT |
| Patient Support Call Centre (PSCC)RAMP Patients can also be referred to the Patient Empowerment Programme(PEP) - a structured self-care education programme delivered by non-governmental organisations(NGOs). If the DM control is suboptimal but the patient is unable to attend the PEP, they may be referred to the Patient Support Call Centre(PSCC) service. PSCC provides individualized telephone counselling by trained nurses. PSCC empowers high-risk DM patients to engage in self-care behaviours by providing regular protocol-led telephone support to advise and reinforce healthy behaviours. Targeted self-care behaviours include self-monitoring, medication management, balanced diet, exercise, risk factor reduction, problem solving and healthy coping. Enrolled patients receive weekly to bi-weekly calls in the first 3 months and additional calls as required for a maximum of 9 months. Subsequent follow-up calls are undertaken to assess self-care behaviours related to the selected goals and to develop a care plan with the patient. | Procedure or surgery | Sub-study 4: PSCC |
Primary outcome
Incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality)
Time frame: 10 years
The disease are defined by the diagnosis codes International Classification of Primary Care, Second edition or International Classification of Diseases,Ninth Revision, Clinical Modification.
Service utilization rate (out-patient clinics, Accident and Emergency and hospitalizations)
Time frame: 10 years
Based on the electronic health record from Hong Kong Hospital Authority
Incremental cost-effectiveness ratio per DM/HT-related complication or all-cause death avoided, and per QALY gained by RAMP or PSCC
Time frame: 10 years
The incremental cost-effectiveness ratio (ICER), that is the ratio of the incremental costs of the RAMP group over the incremental effectiveness, will be calculated for each complication event, or death avoided, and per QALY gain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 33550225Wan EYF, Chin WY, Yu EYT, Chen J, Tse ETY, Wong CKH, Ha TKH, Chao DVK, Tsui WWS, Lam CLK. Retrospective cohort study to investigate the 10-year trajectories of disease patterns in patients with hypertension and/or diabetes mellitus on subsequent cardiovascular outcomes and health service utilisation: a study protocol. BMJ Open. 2021 Feb 5;11(2):e038775. doi: 10.1136/bmjopen-2020-038775.
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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. This study is not recruiting at the moment.
Cindy L.K. Lam, MD principal investigator
Professor and Head of Department of Family Medicine & Primary Care, HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Diabetes Mellitus, run by The University of Hong Kong at 1 site in China.
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 19 inclusion and 4 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: finished, as of the sponsor's last update on 10 Dec 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DM/HT-related complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality) (time frame: 10 years). The study lists 3 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 NCT04302974, 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 10 Dec 2024.