Actively Recruiting
Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness
Led by Amsterdam UMC, location VUmc · Updated on 2024-06-14
258
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the criteria of severe mental illness
- Aged from 18 to 65 years
- Body mass index (BMI) 65 27
- Access and ability to use internet
- Able and willing to sign informed consent
You will not qualify if you...
- Contra-indications due to acute psychiatric crisis or severe somatic diseases as assessed by the treating physician/psychiatrist
- Cognitive impairment interfering with informed consent, questionnaire completion, or intervention participation
- Pregnant or breastfeeding women at the time of inclusion
- Unable to communicate in the Dutch language
AI-Screening
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Trial Site Locations
Total: 1 location
1
Parnassia Groep
The Hague, South Holland, Netherlands, 2553 RJ
Actively Recruiting
Research Team
M
Meike M Hoogervorst
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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