Clinical trial NCT06998511: Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Comorbid Hypertension and Diabetes
Official title: Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Patients With Comorbid Hypertension and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Blood Pressure Control
Glucose Control
Psychosocial Adaptation
Lead sponsor: Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Sponsor class: OTHER_GOV
First posted: 2025-05-31
Enrollment: 187
Sex: ALL
Minimum age (years): 36
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Pressure Control
timeFrame: Baseline and 6 months.
Secondary outcomes:
measure: Quality of Life (SF-36 Scale)
timeFrame: Baseline and 6 months
measure: Psychosocial Adaptation (PAIS-SR Scale)
timeFrame: Baseline and 6 months.
measure: Self-Efficacy (GSES Scale)
timeFrame: Baseline and 6 months.
measure: Nursing Satisfaction (NSNS Scale)
timeFrame: 6 months.
Other outcomes:
measure: Adherence to Intervention
timeFrame: Monthly for 6 months.
Locations:
city: Xiangyang
country: China
facility: Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Study officials:
References: