HypertensionCOMPACT-HTDMNCT07528391
Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus
A study testing Integrated Comorbidity Management Package in people with Hypertension and Diabete Type 2, run by Nanchang University.
Trial summary
The COMPACT-HTDM study is a parallel, two-arm cluster randomized controlled trial designed to evaluate a comorbidity-oriented integrated primary care management model for elderly patients with coexisting hypertension and type 2 diabetes mellitus in community health centers and township health centers. Read more about this study
- Who is it for?
- Ages 60 to 74 years
- Conditions the study is for
- Hypertension, Diabete Type 2, Comorbidities and Coexisting Conditions
- What is being tested?
- Integrated Comorbidity Management Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2028
- 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 60 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cluster level (primary care facilities):
- Township health centers or community health service centers that provide routine primary care management services for both hypertension and diabetes.
- Agree to participate in cluster randomization and study procedures.
- Have basic capacity for chronic disease follow-up and data recording.
- Individual participant level (patients):
- Aged 60 to 74 years.
Show all 9Show fewer
- Diagnosed with hypertension and type 2 diabetes mellitus for at least 6 months.
- Received at least one chronic disease management service at the participating study site within the past 6 months.
- Able to provide written informed consent.
Who cannot join
- Cluster Level (Primary Care Facilities):
- Facilities currently participating in other intervention studies or pilot programs targeting hypertension and/or diabetes management that may interfere with the study intervention.
- Facilities with major organizational instability (e.g., restructuring, closure, or significant staff turnover) that would affect implementation or follow-up.
- Individual Level:
- Severe cognitive impairment or psychiatric illness affecting participation or follow-up.
- Anticipated inability to complete 6-month follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus: A Cluster Randomised Controlled Trial in Rural China
The COMPACT-HTDM study is a parallel, two-arm cluster randomized controlled trial designed to evaluate a comorbidity-oriented integrated primary care management model for elderly patients with coexisting hypertension and type 2 diabetes mellitus in community health centers and township health centers. The trial aims to determine whether an integrated comorbidity management package can improve metabolic control and cardiovascular risk management compared with usual disease-specific care in routine primary care settings. Clusters are primary care facilities randomized 1:1 to intervention or control by an independent statistician using a computer-generated random sequence. Patients aged 60-74 years with diagnosed hypertension and type 2 diabetes for at least six months and recent use of chronic disease management services at the study site will be recruited through chronic disease registries. The intervention includes comorbidity-focused medication optimization and safety management, integrated lifestyle management, self-management and community support, training for primary care staff, standardized toolkits and workflow embedding, an integrated comorbidity management platform, and feedback/incentive mechanisms. The control group will continue current standard primary care management for hypertension and diabetes under existing national guidelines. Participants will be followed for six months, with possible extension to 12 months for longer-term outcomes. The primary outcome is the proportion of participants achieving both blood pressure and glycemic control targets, defined as SBP/DBP <130/80 mmHg and HbA1c <7.0%. Secondary outcomes include BMI, blood lipids, medication adherence, lifestyle behaviors, follow-up completion, referral rate, and safety events such as hypoglycemia and hypotension; implementation outcomes include acceptability, fidelity, and feasibility.
- Being tested
- Integrated Comorbidity Management Package, Usual Care intervention
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Comorbidity Management PackageBehavioural
The intervention is a multi-component, comorbidity-oriented integrated management package for patients with coexisting hypertension and type 2 diabetes mellitus delivered at the primary care level. It includes: (1) standardized assessment and risk stratification for combined cardiometabolic risk; (2) coordinated medication management and optimization for blood pressure and glycemic control, including safety monitoring; (3) integrated lifestyle modification support (diet, physical activity, weight management, and smoking cessation); (4) structured self-management education and community-based support; (5) training and capacity building for primary care providers; (6) use of standardized clinical pathways, toolkits, and digital support systems to facilitate integrated care delivery; and (7) regular follow-up, monitoring, and feedback with performance evaluation and quality improvement mechanisms.
Usual Care interventionOther
Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Comorbidity Management Intervention | Experimental | The intervention is a multi-component, comorbidity-oriented integrated management package for patients with coexisting hypertension and type 2 diabetes mellitus delivered at the primary care level. It includes: (1) standardized assessment and risk stratification for combined cardiometabolic risk; (2) coordinated medication management and optimization for blood pressure and glycemic control, including safety monitoring; (3) integrated lifestyle modification support (diet, physical activity, weight management, and smoking cessation); (4) structured self-management education and community-based support; (5) training and capacity building for primary care providers; (6) use of standardized clinical pathways, toolkits, and digital support systems to facilitate integrated care delivery; and (7) regular follow-up, monitoring, and feedback with performance evaluation and quality improvement mechanisms. Receives: Behavioral: Integrated Comorbidity Management Package |
| Usual Care (Standard Primary Care Management) | Active comparator | Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines. Receives: Other: Usual Care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Combined Blood Pressure and Glycemic Control Using Clinic Blood Pressure Measurement and Laboratory Glycated Hemoglobin (HbA1c)
Proportion of participants who achieve both of the following at 6 months:
Blood pressure control, defined as systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg, assessed by standardized seated clinic blood pressure measurement after 5 minutes of rest; and Glycemic control, defined as HbA1c <7.0%, assessed by laboratory glycated hemoglobin testing.
For blood pressure, two seated measurements are obtained after 5 minutes of rest and the average value is used for outcome assessment. The combined outcome is reported as a binary participant-level endpoint.
Measured: Six months
Secondary outcomes (9)
Blood Pressure Control Rate Using Standardized Clinic Systolic and Diastolic Blood Pressure Measurement
Proportion of participants with systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg at 6 months, assessed using standardized seated clinic blood pressure measurement after 5 minutes of rest. Two measurements are taken and the average is used. Unit of measure: mmHg.
Measured: Six months
Glycemic Control Rate Using Laboratory Glycated Hemoglobin (HbA1c)
Proportion of participants with HbA1c <7.0% at 6 months, assessed by laboratory glycated hemoglobin testing. Unit of measure: percent (%). Lower values indicate better glycemic control.
Measured: Six months
Change in Systolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement
Change in systolic blood pressure from baseline to 6 months, assessed by standardized seated clinic blood pressure measurement after 5 minutes of rest. Two measurements are taken and the average systolic blood pressure is used. Unit of measure: mmHg.
Measured: Baseline to 6 months
Change in Diastolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement
Change in diastolic blood pressure from baseline to 6 months, assessed by standardized seated clinic blood pressure measurement after 5 minutes of rest. Two measurements are taken and the average diastolic blood pressure is used. Unit of measure: mmHg.
Measured: Baseline to 6 months
Change in Laboratory Glycated Hemoglobin (HbA1c) Percentage
Change in HbA1c from baseline to 6 months, assessed by laboratory glycated hemoglobin testing. Unit of measure: percent (%). Lower values indicate better glycemic control.
Measured: Baseline to 6 months
Medication Adherence Assessed by the Adherence to Refills and Medications Scale (ARMS)
Medication adherence is assessed using the Adherence to Refills and Medications Scale (ARMS) included in the questionnaire. The ARMS contains 12 items, each scored from 1 to 4, for a total score range of 12 to 48. Lower scores indicate better medication adherence and higher scores indicate worse adherence. The questionnaire assesses medication-taking and prescription refill behaviors over the past 3 months.
Measured: 6 months
Physical Activity Assessed by the International Physical Activity Questionnaire (IPAQ)
Physical activity is assessed using the International Physical Activity Questionnaire (IPAQ) items in the questionnaire, including vigorous activity, moderate activity, walking, and sitting time over the last 7 days. The primary reported value will be total physical activity in MET-minutes/week, calculated from frequency and duration of vigorous activity, moderate activity, and walking. Higher MET-minutes/week indicate greater physical activity. Sitting time may be summarized separately in minutes/day if reported descriptively.
Measured: Baseline to 6 months
Incidence of Hypoglycemia Assessed by Participant Report and Medical Record Review
Incidence of hypoglycemia events during the intervention period, identified by participant report and/or medical record review. Reported as the proportion of participants with at least one hypoglycemia event.
Measured: During the 6-month intervention period
Incidence of Hypotension Assessed by Participant Report and Medical Record Review
Incidence of hypotension events during the intervention period, identified by participant report and/or medical record review. Reported as the proportion of participants with at least one hypotension event.
Measured: During the 6-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchang University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangdong District General Hospital, Xinfeng County Center for Disease Control and Prevention, Health Commission of Wuyuan County
- Responsible party
- Principal investigator, Xuejun Yin, Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528391
- Sponsor's protocol ID
- 03002
- Acronym
- COMPACT-HTDM
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus: A Cluster Randomised Controlled Trial in Rural China
- ClinicalTrials.gov ID
- NCT07528391
- Acronym / sponsor ID
- COMPACT-HTDM / 03002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Nanchang UniversityUniversity, hospital or other
- Collaborators
- Xiangdong District General Hospital, Xinfeng County Center for Disease Control and Prevention, Health Commission of Wuyuan County
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (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 COMPACT-HTDM study is a parallel, two-arm cluster randomized controlled trial designed to evaluate a comorbidity-oriented integrated primary care management model for elderly patients with coexisting hypertension and type 2 diabetes mellitus in community health centers and township health centers. The trial aims to determine whether an integrated comorbidity management package can improve metabolic control and cardiovascular risk management compared with usual disease-specific care in routine primary care settings. Clusters are primary care facilities randomized 1:1 to intervention or control by an independent statistician using a computer-generated random sequence. Patients aged 60-74 years with diagnosed hypertension and type 2 diabetes for at least six months and recent use of chronic disease management services at the study site will be recruited through chronic disease registries. The intervention includes comorbidity-focused medication optimization and safety management, integrated lifestyle management, self-management and community support, training for primary care staff, standardized toolkits and workflow embedding, an integrated comorbidity management platform, and feedback/incentive mechanisms. The control group will continue current standard primary care management for hypertension and diabetes under existing national guidelines. Participants will be followed for six months, with possible extension to 12 months for longer-term outcomes. The primary outcome is the proportion of participants achieving both blood pressure and glycemic control targets, defined as SBP/DBP <130/80 mmHg and HbA1c <7.0%. Secondary outcomes include BMI, blood lipids, medication adherence, lifestyle behaviors, follow-up completion, referral rate, and safety events such as hypoglycemia and hypotension; implementation outcomes include acceptability, fidelity, and feasibility.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Comorbidity Management Intervention | Experimental | Behavioral: Integrated Comorbidity Management PackageThe intervention is a multi-component, comorbidity-oriented integrated management package for patients with coexisting hypertension and type 2 diabetes mellitus delivered at the primary care level. It includes: (1) standardized assessment and risk stratification for combined cardiometabolic risk; (2) coordinated medication management and optimization for blood pressure and glycemic control, including safety monitoring; (3) integrated lifestyle modification support (diet, physical activity, weight management, and smoking cessation); (4) structured self-management education and community-based support; (5) training and capacity building for primary care providers; (6) use of standardized clinical pathways, toolkits, and digital support systems to facilitate integrated care delivery; and (7) regular follow-up, monitoring, and feedback with performance evaluation and quality improvement mechanisms. |
| Usual Care (Standard Primary Care Management) | Active comparator | Other: Usual Care interventionStandard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines. |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Township health centers or community health service centers that provide routine primary care management services for both hypertension and diabetes.
- Agree to participate in cluster randomization and study procedures.
- Have basic capacity for chronic disease follow-up and data recording.
- Aged 60 to 74 years.
- Diagnosed with hypertension and type 2 diabetes mellitus for at least 6 months.
Key exclusion criteria (6 listed)
- Facilities currently participating in other intervention studies or pilot programs targeting hypertension and/or diabetes management that may interfere with the study intervention.
- Facilities with major organizational instability (e.g., restructuring, closure, or significant staff turnover) that would affect implementation or follow-up.
- Severe cognitive impairment or psychiatric illness affecting participation or follow-up.
- Anticipated inability to complete 6-month follow-up.
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 |
|---|---|---|
| Integrated Comorbidity Management PackageThe intervention is a multi-component, comorbidity-oriented integrated management package for patients with coexisting hypertension and type 2 diabetes mellitus delivered at the primary care level. It includes: (1) standardized assessment and risk stratification for combined cardiometabolic risk; (2) coordinated medication management and optimization for blood pressure and glycemic control, including safety monitoring; (3) integrated lifestyle modification support (diet, physical activity, weight management, and smoking cessation); (4) structured self-management education and community-based support; (5) training and capacity building for primary care providers; (6) use of standardized clinical pathways, toolkits, and digital support systems to facilitate integrated care delivery; and (7) regular follow-up, monitoring, and feedback with performance evaluation and quality improvement mechanisms. | Behavioural | Integrated Comorbidity Management Intervention |
| Usual Care interventionStandard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines. | Other | Usual Care (Standard Primary Care Management) |
Primary outcome
Proportion of Participants Achieving Combined Blood Pressure and Glycemic Control Using Clinic Blood Pressure Measurement and Laboratory Glycated Hemoglobin (HbA1c)
Time frame: Six months
Proportion of participants who achieve both of the following at 6 months: Blood pressure control, defined as systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg, assessed by standardized seated clinic blood pressure measurement after 5 minutes of rest; and Glycemic control, defined as HbA1c <7.0%, assessed by laboratory glycated hemoglobin testing. For blood pressure, two seated measurements are obtained after 5 minutes of rest and the average value is used for outcome assessment. The combined outcome is reported as a binary participant-level endpoint.
9 secondary outcomes
Blood Pressure Control Rate Using Standardized Clinic Systolic and Diastolic Blood Pressure Measurement
Time frame: Six months
Glycemic Control Rate Using Laboratory Glycated Hemoglobin (HbA1c)
Time frame: Six months
Change in Systolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement
Time frame: Baseline to 6 months
Change in Diastolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement
Time frame: Baseline to 6 months
Change in Laboratory Glycated Hemoglobin (HbA1c) Percentage
Time frame: Baseline to 6 months
Medication Adherence Assessed by the Adherence to Refills and Medications Scale (ARMS)
Time frame: 6 months
Physical Activity Assessed by the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline to 6 months
Incidence of Hypoglycemia Assessed by Participant Report and Medical Record Review
Time frame: During the 6-month intervention period
Incidence of Hypotension Assessed by Participant Report and Medical Record Review
Time frame: During the 6-month intervention period
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 14 Apr 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Comorbidity Management Package in people with Hypertension and Diabete Type 2, run by Nanchang University.
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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Xuejun Yin, PhD (18600988138, xuejun.yin@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Combined Blood Pressure and Glycemic Control Using Clinic Blood Pressure Measurement and Laboratory Glycated Hemoglobin (HbA1c) (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.