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

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• Metabolic Syndrome 1,964
• Mental Disorders 2,107

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 258 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Lead sponsor

Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.

Study arms

• Experimental
  GILL eHealth module

  Patients will perform the GILL eHealth. This eHealth contains two modules focusing on systematic somatic screening and lifestyle behaviors.

  Device: GILL eHealth

• No intervention
  Care as usual

  Patients will receive usual care and have unrestricted access to mental care and treatment.

Interventions

• DeviceGILL eHealth

  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.

Primary outcomes

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.

   Time frame: 12 months

Secondary outcomes

1. Weight (kg)

   Weight is an indication for physical health.

   Time frame: 12 months

2. Length (m)

   Length will be measured to calculate the BMI.

   Time frame: 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.

   Time frame: 12 months

4. Diastolic blood pressure (mmHg)

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

   Time frame: 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.

   Time frame: 12 months

6. HbA1c (mmol/l)

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

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 months

Other outcomes

1. Demographics

   Age, gender, ethnicity, marital status, education level, employment status, psychiatric diagnoses, diagnosesof somatic diseases, current smoking status, number of years receiving mental care, and medication use.

   Time frame: 12 months

2. Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)

   The TIC-P is a validated questionnaire designed for self-report in adult patients with a mental disorder to assess their utilization of the medical health care costs. The TIC-P items that will be used include 14 structured questions on the volume of medical costs, e.g. ambulatory services, private practice, and general practitioner. A higher outcome value means more health care costs.

   Time frame: 12 months

Individual participant data

Plan to share: 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.