Interdisciplinary Collaborative Care Model Combined With Family Empowerment in Patients With Comorbid Hypertension and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Blood Pressure Control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 36 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
routine nursing intervention
The control group received routine nursing intervention, including basic drug treatment, diet and exercise guidance, psychological counseling, etc.
干预措施: routine nursing intervention (Other)
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.
干预措施: interdisciplinary collaborative care and family empowerment (ICCM-FE) intervention (Other)
结局指标
主要结局
Blood Pressure Control
时间窗: Baseline and 6 months.
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months post-intervention.
次要结局
- 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.)
研究者
Qiqi Wu
Principal Investigator
Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science