Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAmsterdam UMC, location VUmc

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • GILL eHealth

    Device

    The 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

258 Participants
are divided into 2 treatment groups
Group A: GILL eHealth moduleExperimental treatment 1 intervention
Group B: Care as usualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

Weight (kg)

Weight is an indication for physical health.

Time frame
12 months
2

Length (m)

Length will be measured to calculate the BMI.

Time frame
1 measurement
3

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.

Time frame
12 months
4

Diastolic blood pressure (mmHg)

A healthy score of the diastolic blood pressure lies between 60 and 80 mmHg.

Time frame
12 months

Other outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC, location VUmc

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator