Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Comorbid Hypertension and Diabetes
1 other identifier
interventional
187
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2024
CompletedFirst Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 31, 2025
CompletedMay 31, 2025
May 1, 2025
8 months
May 6, 2025
May 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Blood Pressure Control
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months post-intervention.
Baseline and 6 months.
Secondary Outcomes (4)
Quality of Life (SF-36 Scale)
Baseline and 6 months
Psychosocial Adaptation (PAIS-SR Scale)
Baseline and 6 months.
Self-Efficacy (GSES Scale)
Baseline and 6 months.
Nursing Satisfaction (NSNS Scale)
6 months.
Other Outcomes (1)
Adherence to Intervention
Monthly for 6 months.
Study Arms (2)
routine nursing intervention
OTHERThe control group received routine nursing intervention, including basic drug treatment, diet and exercise guidance, psychological counseling, etc.
interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention
OTHERThe observation group received interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention based on the COM-B model on the basis of routine care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
Xiangyang, 441138, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 31, 2025
Study Start
January 7, 2023
Primary Completion
September 5, 2023
Study Completion
March 16, 2024
Last Updated
May 31, 2025
Record last verified: 2025-05