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

Amsterdam UMC, location VUmc

Status: Enrolling

Conditions: Lifestyle; eHealth; Severe Mental Disorder; Somatic Screening; Metabolic Syndrome

Treatments: Device: GILL eHealth

Study type: Interventional

Funder types: Other

Identifiers

NCT05533749

NL81729.029.22

Details and patient eligibility

About

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.

Enrollment: 258 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

258 participants in 2 patient groups

GILL eHealth module

Experimental group

Description:

Patients will perform the GILL eHealth. This eHealth contains two modules focusing on systematic somatic screening and lifestyle behaviors.

Treatment:

Device: GILL eHealth

Care as usual

No Intervention group

Description:

Patients will receive usual care and have unrestricted access to mental care and treatment.