Primary objective (after 1 year)- To evaluate the effectiveness of the nurse-led GILL eHealth intervention in patients with serious mental illnessSecundary objectives (after 1 year)- Improve metabolic syndrome severity- Improve fitness, physical…
ID
Source
Brief title
Condition
- Depressed mood disorders and disturbances
- Personality disorders and disturbances in behaviour
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>The primary study parameter is the metabolic syndrome severity, which is operationalized by the Metabolic Syndrome Severity Score (MSSS).</p>
Secondary outcome
<p>Secondary study parameters are physical fitness, physical activity, perceived lifestyle behaviours, quality of life, recovery, psychosocial functioning, health related self-efficacy, health care utilization, and medication use.</p>
Background summary
Patients with serious mental illness (SMI) have overall poor physical health. SMI reduces life expectancy with 15-20 years, primarily due to somatic comorbidity linked to cardiometabolic risk factors. Systematic somatic screening and lifestyle promotion are the basis to assist persons with serious mental illness in improving their somatic health, including reducing cardiometabolic risk.
The use of eHealth tools is recommended for the effective implementation of the structured somatic screening and lifestyle promotion. However, only a small number of these applications are specifically tailored for use for patients with serious mental illness. Thoroughly testing of eHealth interventions for patients with SMI is also sparse. For the Dutch patients with SMI, the GILL eHealth has been developed. It is, however, currently unknown whether the nurse-led GILL eHealth intervention program is effective in improving physical
health and lifestyle behaviors.
Study objective
Primary objective (after 1 year)
- To evaluate the effectiveness of the nurse-led GILL eHealth intervention in patients with serious mental illness
Secundary objectives (after 1 year)
- Improve metabolic syndrome severity
- Improve fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning health related self-efficacy, and health care utilization
- Obtain insight in feasibility and acceptability to implementation about the GILL eHealth intervention
Study design
This study is a cluster randomized controlled trial with a follow-up period of 1 year. To evaluate the effectiveness of the intervention, it will be compared to usual care. Eligible participants will be randomly allocated to the GILL eHealth or usual care. This multicentre study will recruit 258 participants from approximately 20 teams (FACT, supported housing or long-stay wards) across the Netherlands. Including inclusion of participants, analysis and reporting phase, the total duration of the study will be 48 months.
Intervention
The provided intervention is the nurse-led GILL eHealth. This eHealth contains two modules: OurGILL and MyGILL. OurGILL focuses on systematic somatic screening and provides an overview of all somatic abnormalities. MyGILL is about lifestyle behaviours and provides the basis for drawing up a personalized lifestyle plan.
Study burden and risks
With participating, patients have the opportunity to adjust their lifestyle, which can possibly improve their mental and physical health.
Burden: During this study, the participants will be assessed at three points in time (baseline, 6- and 12-month follow-up). A selection of participants will take part in qualitative interviews. Patients of the intervention group will form a lifestyle behaviour plan. The lifestyle adaptation can been seen as a bit of a burden.
Risks: There are no risks when participating in this intervention
M.M. Hoogervorst
Oldenaller 1
Amsterdam 1081HJ
Netherlands
0629680823
m.m.hoogervorst@amsterdamumc.nl
M.M. Hoogervorst
Oldenaller 1
Amsterdam 1081HJ
Netherlands
0629680823
m.m.hoogervorst@amsterdamumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Diagnosis of schizophrenia, other psychotic disorder and/or disorders defined as serious mental illness according to Delespaul consensusgroup at Maastricht University
- Aged from 18 and older
- Body mass index (BMI) >= 27
- Access and ability to use internet
Exclusion criteria
- Contra-indications (to be assessed by the threating physician/psychiatrist) for participation due to acute psychiatric crisis or severe somatic diseases
- Pregnancy or breastfeeding in women at the time of inclusion
- 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
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05533749 |
| CCMO | NL81729.029.22 |
| Research portal | NL-007309 |