AzTrials
AzTrials

Severe Mental DisorderGILLNCT05533749

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

A study testing GILL eHealth in people with Severe Mental Disorder and Metabolic Syndrome, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
GILL eHealth
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
1 siteNetherlands
Study dates
30 May 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Meike M Hoogervorst contact

+31629680823

m.m.hoogervorst@amsterdamumc.nl

Netherlands1 site, 1 recruiting

  • Parnassia Groep

    The Hague, South Holland, 2553 RJ

    Berno Van Meijel, Prof. dr.

    Recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
GILL eHealth
Medical subject headings
Mental Disorders, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GILL eHealthDevice

    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.

Study groups in NCT05533749
Study groupRoleWhat they receive
GILL eHealth moduleExperimentalPatients will perform the GILL eHealth. This eHealth contains two modules focusing on systematic somatic screening and lifestyle behaviors.
Receives: Device: GILL eHealth
Care as usualNo interventionPatients will receive usual care and have unrestricted access to mental care and treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic Syndrome Severity Score (MSSS)

    The MSSS includes the components sex, age, ethnicity, systolic blood pressure (mmHg), waistline circumference (cm), high-density lipoprotein, triglycerides and fasting blood glucose. A lower score is considered better.

    Measured: 12 months

Secondary outcomes (13)

  1. Weight (kg)

    Weight is an indication for physical health.

    Measured: 12 months

  2. Length (m)

    Length will be measured to calculate the BMI.

    Measured: 1 measurement

  3. Body Mass Index (kg/m2)

    Body Mass Index (BMI) will be determined using the measured weight and length. A BMI between 18.5 and 25 is considered healthy.

    Measured: 12 months

  4. Diastolic blood pressure (mmHg)

    A healthy score of the diastolic blood pressure lies between 60 and 80 mmHg.

    Measured: 12 months

  5. Lipid profiles (mmol/l)

    LDL and total cholesterol will be determined. For the LDL a score below 3,0 mmol/l is considered good for healthy participants, participants with additional risks for cardiovascular diseases should have a score below 2.6 mmol/l, and for participants with a cardiovascular disease the score should be below 1.8 mmol/l. Overall, a lower LDL score is considered better. For the total cholesterol a score below 5.0 mmol/l is considered healthy.

    Measured: 12 months

  6. HbA1c (mmol/l)

    HbA1c is a measurement outcome to determine blood glucose. A score below 53 is considered healthy.

    Measured: 12 months

  7. Six-minute walk test (6MWT)

    The 6MWT is a measurement to assess physical fitness. It measures the walking distance in 6 minutes. A higher score indicates a longer distance walked and a better physical fitness.

    Measured: 12 months

  8. International Physical Activity Questionnaire Short Form (IPAQ-SF)

    The IPAQ-SF is a 10-item self-report questionnaire where participants recall the number of days and minutes of vigorous activity, moderate activity, walking and sitting time, over the past 7 days. A higher score indicates more physical activity.

    Measured: 12 months

  9. Numeric Rating Scale (NRS)

    The NRS will be used to determine the perceived physical health, physical activity and healthy eating of the past 4 weeks on a scale from 0-10. A higher score is considered better.

    Measured: 12 months

  10. Short Form-12

    This is a generic, reliable and validated instrument to assess quality of life, containing 12 items derived from the Short Form 36 questionnaire. Physical and mental quality of life will be measured using the physical and mental component summary of the SF-12, respectively. A higher scores indicates a better health status.

    Measured: 12 months

  11. Questionnaire about Processes of Recovery (QPR)

    The QPR is a self-report 15-item questionnaire with a score range of 0-60 (QPR total). Higher scores are indicative of recovery.

    Measured: 12 months

  12. Health of the Nation Outcome Scale (HoNOS)

    The HoNOS is a clinician-rated instrument comprising twelve items on four domains (behavioral problems, organic problems, psychological symptoms, social problems), each item ranging from 0 (no problems) to 4 (severe problems). A lower score is considered better.

    Measured: 12 months

  13. Patient Activation Measure (PAM-13)

    The questionnaire assesses the participants' self-reported knowledge, skills and confidence for health-related self-efficacy. A higher score is considered better.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2022
  2. Study start30 May 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05533749
Sponsor's protocol ID
NL81729.029.22
Acronym
GILL
Status last verified
Jun 2024
First submitted
25 Aug 2022
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be intellectual property of the research team, and will be available for others in case of requests after publication of the results according to privacy regulations.

Publications

  • 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.

    PubMed 37715156

Questions about this trial

What is this clinical trial studying?

A study testing GILL eHealth in people with Severe Mental Disorder and Metabolic Syndrome, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Meike M Hoogervorst (+31629680823, m.m.hoogervorst@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic Syndrome Severity Score (MSSS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05533749, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in