Clinical trial NCT05533749: Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness
Official title: Improving Physical Health and Lifestyle Behaviors in Patients With Serious Mental Illness: a Cluster Randomized Controlled Trial on the Effectiveness of the Nurse-led GILL eHealth Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Mental Disorder
Metabolic Syndrome
Lifestyle
Somatic Screening
eHealth
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-09-09
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Metabolic Syndrome Severity Score (MSSS)
timeFrame: 12 months
Secondary outcomes:
measure: Weight (kg)
timeFrame: 12 months
measure: Length (m)
timeFrame: 1 measurement
measure: Body Mass Index (kg/m2)
timeFrame: 12 months
measure: Diastolic blood pressure (mmHg)
timeFrame: 12 months
measure: Lipid profiles (mmol/l)
timeFrame: 12 months
measure: HbA1c (mmol/l)
timeFrame: 12 months
measure: Six-minute walk test (6MWT)
timeFrame: 12 months
measure: International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 12 months
measure: Numeric Rating Scale (NRS)
timeFrame: 12 months
measure: Short Form-12
timeFrame: 12 months
measure: Questionnaire about Processes of Recovery (QPR)
timeFrame: 12 months
measure: Health of the Nation Outcome Scale (HoNOS)
timeFrame: 12 months
measure: Patient Activation Measure (PAM-13)
timeFrame: 12 months
Other outcomes:
measure: Demographics
timeFrame: 12 months
measure: Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
timeFrame: 12 months
Locations:
city: Den Haag
country: Netherlands
facility: Parnassia Groep
state: Zuid-Holland
Study officials:
References: