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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06998511
Enrollment
187
Registered
2025-05-31
Start date
2023-01-07
Completion date
2024-03-16
Last updated
2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure Control, Diabetes, Glucose Control, Hypertension, Psychosocial Adaptation

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.

Interventions

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

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.

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
36 Years to 58 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Quality of Life (SF-36 Scale)Baseline and 6 monthsChange in SF-36 scores across eight domains (physical function, mental health, role limitations, etc.) from baseline to 6 months post-intervention.
Psychosocial Adaptation (PAIS-SR Scale)Baseline and 6 months.Change in psychosocial adjustment scores (healthcare orientation, occupational/family environment, psychological stress, etc.) from baseline to 6 months post-intervention.
Self-Efficacy (GSES Scale)Baseline and 6 months.Change in General Self-Efficacy Scale (GSES) scores from baseline to 6 months post-intervention.
Nursing Satisfaction (NSNS Scale)6 months.Patient satisfaction with nursing care measured using the Newcastle Satisfaction with Nursing Services Scale (NSNS) at 6 months post-intervention.

Other

MeasureTime frameDescription
Adherence to InterventionMonthly for 6 months.Compliance rates with the interdisciplinary collaborative care model (ICCM-FE) assessed via follow-up attendance and task completion logs.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026