About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the criteria of severe mental illness
Aged from 18 to 65 years
Body mass index (BMI) ≥ 27
Access and ability to use internet
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
GILL eHealth
DeviceThe aim of the successfully pilot-tested GILL eHealth intervention is to support mental health nurses and clinical nurse specialists in structured somatic screening and lifestyle promotion. The GILL eHealth intervention consists of two parts. Part one is OurGILL which focuses on systematic somatic screening and provides an overview of all somatic abnormalities. It promotes the prevention, early recognition and treatment of somatic problems. The second part is MyGILL. It provides the basis for drawing up a personalized lifestyle plan. The result of MyGILL is an overview of the performance of patients in different lifestyle areas. The eHealth intervention consists of an individual internet environment and is also supported by an app for mobile devices.
Treatment groups
Trial outcomes
Primary outcomes
Metabolic Syndrome Severity Score (MSSS)
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.
Secondary outcomes
Weight (kg)
Weight is an indication for physical health.
Length (m)
Length will be measured to calculate the BMI.
Body Mass Index (kg/m2)
Body Mass Index (BMI) will be determined using the measured weight and length. A BMI between 18.5 and 25 is considered healthy.
Diastolic blood pressure (mmHg)
A healthy score of the diastolic blood pressure lies between 60 and 80 mmHg.
Other outcomes
Demographics
Age, gender, ethnicity, marital status, education level, employment status, psychiatric diagnoses, diagnosesof somatic diseases, current smoking status, number of years receiving mental care, and medication use.
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
The TIC-P is a validated questionnaire designed for self-report in adult patients with a mental disorder to assess their utilization of the medical health care costs. The TIC-P items that will be used include 14 structured questions on the volume of medical costs, e.g. ambulatory services, private practice, and general practitioner. A higher outcome value means more health care costs.
Sponsors and contacts
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Amsterdam UMC, location VUmc
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator