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

Study Overview
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Brief Summary
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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. 246 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.

Official Title
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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

Conditions
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Severe Mental Disorder, Metabolic Syndrome, Lifestyle, Somatic Screening, eHealth

Intervention / Treatment
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* Device: GILL eHealth


Participation Criteria
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Eligibility Criteria
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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 and mobile device 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GILL eHealth module<br>Patients will perform the GILL eHealth. This eHealth contains two modules focusing on systematic somatic screening and lifestyle behaviors. | Device: GILL eHealth<br>* 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.<br>|
| No Intervention: Care as usual<br>Patients will receive usual care and have unrestricted access to mental care and treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) | Weight is an indication for physical health. | 12 months | 
| Length (m) | Length will be measured to calculate the BMI. | 1 measurement | 
| 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. | 12 months | 
| Diastolic blood pressure (mmHg) | A healthy score of the diastolic blood pressure lies between 60 and 80 mmHg. | 12 months | 
| 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. | 12 months | 
| HbA1c (mmol/l) | HbA1c is a measurement outcome to determine blood glucose. A score below 53 is considered healthy. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| Visual Analogue Scale (VAS) | The VAS will be used to determine the perceived physical health, physical activity and healthy eating of the past 4 weeks on a scale from 0-100. A higher score is considered better. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months | 
| 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. | 12 months |