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
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the metabolic syndrome severity, which is
operationalized by the Metabolic Syndrome Severity Score (MSSS).
Secondary outcome
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.
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
Oldenaller 1
Amsterdam 1081HJ
NL
Oldenaller 1
Amsterdam 1081HJ
NL
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 to 65 years
- 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
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 |