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

NCT ID: NCT05533749

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Mental Disorder Metabolic Syndrome Lifestyle Somatic Screening eHealth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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GILL eHealth module

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

Group Type EXPERIMENTAL

GILL eHealth

Intervention Type 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.

Care as usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GILL eHealth

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Berno van Meijel

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parnassia Groep

The Hague, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Meike M Hoogervorst

Role: CONTACT

+31629680823

Facility Contacts

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Berno Van Meijel, Prof. dr.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37715156 (View on PubMed)

Other Identifiers

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NL81729.029.22

Identifier Type: -

Identifier Source: org_study_id

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