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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-07

Study Completion Date

2024-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Integrative Nursing Based Multimodal Interventions for Uncontrolled Hypertensives

NCT04809519

Uncontrolled Hypertension Treatment Compliance Behavior, Health +1 more

COMPLETED NA

Control of Hypertension and diAbetes in MINas Gerais

NCT05660928

Arterial Hypertension Diabetes Mellitus

COMPLETED NA

Telehealth Integrated Care Model in Patients With Cardiometabolic Disease

NCT06022575

Cardiometabolic Disease Hyperlipidemia

UNKNOWN

Adaptive Intervention Model for Hypertension Self-Management in Rural Areas: A Doctor-Patient Interaction Approach

NCT06869031

Hypertension Self-management Hypertension

RECRUITING NA

Effectiveness of Implementation of a Patient-centered Self-management Program in Patients With Hypertensive Nephropathy

NCT04633993

Hypertensive Nephropathy Self-management Self-efficacy +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Diabetes Blood Pressure Control Glucose Control Psychosocial Adaptation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

routine nursing intervention

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

Group Type OTHER

routine nursing intervention

Intervention Type OTHER

The 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

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.

Group Type OTHER

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

interdisciplinary 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.

Intervention Type OTHER

routine nursing intervention

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

36 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No