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NCT Number: NCT07528391

Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Comorbidities and Coexisting Conditions Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

60 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
  • 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.

Exclusion criteria

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.

Treatment and study plan

Integrated Comorbidity Management Package

Behavioral

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 intervention

Other

Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Blood Pressure Control Rate Using Standardized Clinic Systolic and Diastolic Blood Pressure Measurement

    Time frame: Six months

    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.

  2. Glycemic Control Rate Using Laboratory Glycated Hemoglobin (HbA1c)

    Time frame: Six months

    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.

  3. 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 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.

  4. 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 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.

  5. Change in Laboratory Glycated Hemoglobin (HbA1c) Percentage

    Time frame: Baseline to 6 months

    Change in HbA1c from baseline to 6 months, assessed by laboratory glycated hemoglobin testing. Unit of measure: percent (%). Lower values indicate better glycemic control.

  6. Medication Adherence Assessed by the Adherence to Refills and Medications Scale (ARMS)

    Time frame: 6 months

    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.

  7. Physical Activity Assessed by the International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline to 6 months

    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.

  8. Incidence of Hypoglycemia Assessed by Participant Report and Medical Record Review

    Time frame: During the 6-month intervention period

    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.

  9. Incidence of Hypotension Assessed by Participant Report and Medical Record Review

    Time frame: During the 6-month intervention period

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuejun Yin, PhD

CONTACT

[email protected]

18600988138

Sponsors and collaborators

Lead sponsor

Nanchang University

Other

Collaborators

  • Health Commission of Wuyuan County
  • Xiangdong District General Hospital
  • Xinfeng County Center for Disease Control and Prevention

Registry information

Official study title

Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus: A Cluster Randomised Controlled Trial in Rural China

Acronym: COMPACT-HTDM

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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