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Completed

NCT Number: NCT06998511

Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Comorbid Hypertension and Diabetes

The Iinterdisciplinary collaborative care model combined with family empowerment (ICCM-FE) intervention based on the COM-B model can effectively improve blood pressure and glucose control in patients with comorbid hypertension and diabetes, enhance their quality of life and psychosocial adaptation, and significantly increase patient satisfaction with nursing care. This intervention has important clinical application value.

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Key information

Conditions

Hypertension Blood Pressure Control Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Control Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Psychosocial Adaptation Vascular Diseases

Age range

36 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science

Xiangyang, 441138, China

About this study

To evaluate the efficacy of an interdisciplinary collaborative care model combined with family empowerment (ICCM-FE) based on the COM-B model in managing comorbid hypertension and diabetes, focusing on its impact on blood pressure, glucose control, and psychosocial adaptation. This prospective randomized controlled trial (RCT) enrolled 187 patients with comorbid hypertension and diabetes from January 2023 to March 2024. Patients were randomly assigned to a control group (n = 93) receiving routine care and an observation group (n = 94) receiving ICCM-FE intervention. Follow-up was conducted over 6 months, assessing blood pressure (SBP and DBP), glucose levels (FPG and HbA1c), quality of life (SF-36 scale), psychosocial adaptation (PAIS-SR scale), and nursing satisfaction (NSNS scale) pre- and post-intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients met the diagnostic criteria for hypertension and diabetes as specified in the 《2020 International Society of Hypertension Global Hypertension Practice Guidelines》and the 《2020 American Diabetes Association (ADA) Standards of Medical Care in Diabetes》 ;
  • had at least one caregiver, and both the patient and caregiver had basic communication and comprehension abilities to cooperate with the nursing interventions and complete the questionnaires;
  • voluntarily participated in the study and signed an informed consent form;
  • complete follow-up records.

Exclusion criteria

  • severe organ dysfunction or mental illness;
  • malignancies, severe cardiovascular events (e.g., stroke, myocardial infarction);
  • severe hepatic or renal impairment;
  • poor adherence or life expectancy less than 1 year.

Treatment and study plan

interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention

Other

The observation group received interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention based on the COM-B model on the basis of routine care.

routine nursing intervention

Other

The control group received routine nursing intervention, including basic drug treatment, diet and exercise guidance, psychological counseling, etc.

Primary outcomes

  1. Blood Pressure Control

    Time frame: Baseline and 6 months.

    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months post-intervention.

Secondary outcomes

  1. Quality of Life (SF-36 Scale)

    Time frame: Baseline and 6 months

    Change in SF-36 scores across eight domains (physical function, mental health, role limitations, etc.) from baseline to 6 months post-intervention.

  2. Psychosocial Adaptation (PAIS-SR Scale)

    Time frame: Baseline and 6 months.

    Change in psychosocial adjustment scores (healthcare orientation, occupational/family environment, psychological stress, etc.) from baseline to 6 months post-intervention.

  3. Self-Efficacy (GSES Scale)

    Time frame: Baseline and 6 months.

    Change in General Self-Efficacy Scale (GSES) scores from baseline to 6 months post-intervention.

  4. Nursing Satisfaction (NSNS Scale)

    Time frame: 6 months.

    Patient satisfaction with nursing care measured using the Newcastle Satisfaction with Nursing Services Scale (NSNS) at 6 months post-intervention.

Other outcomes

  1. Adherence to Intervention

    Time frame: Monthly for 6 months.

    Compliance rates with the interdisciplinary collaborative care model (ICCM-FE) assessed via follow-up attendance and task completion logs.

Sponsors and collaborators

Lead sponsor

Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science

Other Gov

Registry information

Official study title

Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Patients With Comorbid Hypertension and Diabetes

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 31, 2025
Registry last updated
May 31, 2025

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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