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

NCT05533749 | Recruiting

• 1 other identifier: NL81729.029.22
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

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.

  12 months

Secondary Outcomes (13)

• Weight (kg)

  12 months

• Length (m)

  1 measurement

• Body Mass Index (kg/m2)

  12 months

• Diastolic blood pressure (mmHg)

  12 months

• Lipid profiles (mmol/l)

  12 months

Other Outcomes (2)

• Demographics

  12 months

• Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)

  12 months

Study Arms (2)

GILL eHealth module

EXPERIMENTAL

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

Device: GILL eHealth

Care as usual

NO INTERVENTION

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

Interventions

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.

GILL eHealth module

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subject not able to communicate in the Dutch language

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Parnassia Groep

The Hague, South Holland, 2553 RJ, Netherlands

RECRUITING

Related Publications (1)

• Hoogervorst MM, van Meijel B, Bruin EK, Beekman A, Boonstra N, Adriaanse M. The nurse-led GILL eHealth intervention for improving physical health and lifestyle behaviours in clients with severe mental illness: design of a cluster-randomised controlled trial. BMC Psychiatry. 2023 Sep 15;23(1):672. doi: 10.1186/s12888-023-05024-z.

  PMID: 37715156 DERIVED

MeSH Terms

Conditions

Mental Disorders; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Meike M Hoogervorst

CONTACT

+31629680823; m.m.hoogervorst@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Participants will be randomized to the intervention group or to care as usual. In the intervention group patients will receive the GILL eHealth intervention focusing on systematic somatic screening and lifestyle behaviours.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 9, 2022
• Study Start: May 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)