Improving Physical Health and Lifestyle Behaviors in Patients With Serious Mental Illness: a Cluster Randomized Controlled Trial on the Effectiveness of the Nurse-led GILL eHealth Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Metabolic Syndrome Severity Score (MSSS)
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of the nurse-led GILL (Gezondheid in Lichaam en Leefstijl) eHealth intervention in patients with serious mental illness (SMI), compared to usual care. Expected is that the GILL eHealth intervention will be more effective than usual care in improving physical health and lifestyle behaviors. To evaluate this, we will perform a cluster randomized controlled trial with an embedded process evaluation of the implementation of the GILL intervention. 258 adult patients with serious mental illness and a body mass index of 27 or higher (overweight/obesity) will be included. The GILL eHealth intervention consists of two complementary modules for (a) somatic screening and (b) lifestyle promotion, resulting in a personalized somatic treatment and lifestyle plan. Trained mental health nurses and clinical nurse specialists will implement the intervention within the multidisciplinary treatment context, and will guide and support the patients in the promotion of their somatic health, including cardiometabolic risk management. The intervention will be compared to usual care, which includes treatment according to national guidelines. The outcome measures will be metabolic syndrome severity (primary), fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, health related self-efficacy and health care utilization after 1 year. The process evaluation focuses on the feasibility of the eHealth intervention, its acceptability for patients and health care providers (mainly mental health nurses and clinical nurse specialists), and barriers/facilitators to implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the criteria of severe mental illness
- •Aged from 18 to 65 years
- •Body mass index (BMI) ≥ 27
- •Access and ability to use internet
- •Able and willing to sign informed consent
排除标准
- •Contra-indications (to be assessed by the treating physician/psychiatrist) for participation due to acute psychiatric crisis or severe somatic diseases
- •Subjects with a cognitive impairment sufficient to interfere with their ability to provide informed consent, complete study questionnaires, or participate in the intervention
- •Pregnant or breastfeeding women at the time of inclusion
- •Subject not able to communicate in the Dutch language
研究组 & 干预措施
GILL eHealth module
Patients will perform the GILL eHealth. This eHealth contains two modules focusing on systematic somatic screening and lifestyle behaviors.
干预措施: GILL eHealth (Device)
Care as usual
Patients will receive usual care and have unrestricted access to mental care and treatment.
结局指标
主要结局
Metabolic Syndrome Severity Score (MSSS)
时间窗: 12 months
The MSSS includes the components sex, age, ethnicity, systolic blood pressure (mmHg), waistline circumference (cm), high-density lipoprotein, triglycerides and fasting blood glucose. A lower score is considered better.
次要结局
- Diastolic blood pressure (mmHg)(12 months)
- Lipid profiles (mmol/l)(12 months)
- HbA1c (mmol/l)(12 months)
- Numeric Rating Scale (NRS)(12 months)
- International Physical Activity Questionnaire Short Form (IPAQ-SF)(12 months)
- Questionnaire about Processes of Recovery (QPR)(12 months)
- Weight (kg)(12 months)
- Length (m)(1 measurement)
- Body Mass Index (kg/m2)(12 months)
- Six-minute walk test (6MWT)(12 months)
- Health of the Nation Outcome Scale (HoNOS)(12 months)
- Short Form-12(12 months)
- Patient Activation Measure (PAM-13)(12 months)
研究者
Berno van Meijel
Prof. dr.
Amsterdam UMC, location VUmc