Study Protocol of the EMPOWER-SUSTAIN Project

Study Design:

This is a pilot randomised controlled trial. The overall duration of the study is one year, and the duration of the intervention is 6 months. Blinding is not possible due to the nature and complexity of the intervention. The reporting of this paper is done in accordance with the SPIRIT 2013 guidance for protocols of clinical trials and the CONSORT checklist for pilot and feasibility trials. Figure 1 shows the EMPOWER-SUSTAIN CONSORT Flow Diagram.

Study Population:

The study population will comprise of individuals who are diagnosed with Metabolic Syndrome (MetS) according to the Joint Interim Statement (JIS) on MetS definition, 2009 by the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity.

According to the JIS definition, MetS is defined by the presence of at least 3 out of 5 of the following risk factors:

1. Waist Circumference (WC): M ≥ 90 cm F ≥ 80 cm (South Asian cut-points) II. Blood Pressure (BP): Systolic BP ≥ 130 and/or diastolic BP ≥ 85 mmHg or on treatment for hypertension (HPT) III. Fasting Blood Glucose (FBG): ≥ 5.6 mmol/L or on treatment for elevated glucose IV. Triglycerides (TG): ≥ 1.7 mmol/L or on treatment for TG V. High density lipoprotein cholesterol (HDL-c): Male < 1.0 mmol/L, Female < 1.3 mmol/L; or on treatment for HDL-c

Patient Recruitment:

Consecutive patients who attend the UiTM Primary Care Clinic during the recruitment period will be approached, given the patient information sheet about the study and invited to participate. Those who are willing to participate will be interviewed and screened by the investigators to identify eligibility based on the inclusion and exclusion criteria. Written informed consent will be obtained from those who are eligible and they will be recruited into the study.

Physician Recruitment:

All primary care physician (PCP) who are practicing at the university primary care clinic will be invited to participate in the study. To be eligible, the following criteria must be met:

1. have one or more years of working experience in a primary care setting
2. must be keen to participate in the study
3. willing to deliver the EMPOWER-SUSTAIN e-Health Intervention to patients with MetS

The Intervention:

The EMPOWER-SUSTAIN Self-Management e-Health Intervention is a complex intervention involving multifaceted components based on the CCM and persuasive technology approach. A comprehensive review of the literature was conducted to identify the crucial components of e-health intervention that could improve patient activation and self-management behaviours. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategies based on the CCM and persuasive technology theory. It consists of training physicians and patients to use the EMPOWER-SUSTAIN web-based self-management intervention mobile apps, strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines for management and prescribing.

Conduct of the EMPOWER-SUSTAIN Workshop:

Prior to the intervention, PCP and patient with MetS in the intervention arm will be trained on the EMPOWER-SUSTAIN web-based desktop and mobile applications utilisation in the EMPOWER-SUSTAIN Workshop.

Delivery of the Intervention:

The EMPOWER-SUSTAIN Self-Management e-Health Intervention will be professionally delivered to the individual patient by the PCP. Patients will also be given the EMPOWER-SUSTAIN Global CV Risks Self-Management Booklet©. Follow-up care by the PCP will be arranged at baseline, 3-month and 6-month. At baseline, PCP assisted by a nurse, will go through each section with the patient and will ensure that information recorded in all sections is complete. PCP will discuss self-management progress and goals using this tool with the patient at each follow-up visit. Patients will be able to review their progress at home and use the tool to aid self-management of their MetS e.g. self-monitoring of their weight, BP and blood glucose, recording of their physical activity and diet.

Monitoring the Intervention:

During the 6-month intervention period, patients are required to utilize the EMPOWER-SUSTAIN web-based self-management tool for a cumulative period of two hours duration, and be seen at least once by the PCP for follow-up care. A separate web interface will be created for PCP to monitor patient's log-in frequency and duration of utilisation of the tool. Patients who do not comply with the utilization and follow-up requirements will be considered as lost to follow-up. Patients who are lost to follow-up or who withdraw from the trial will not be replaced. Analysis will be by intention to treat. There is no limit to the number of clinic visit a patient is allowed to make in either arm during the course of the study.

Study Tools:

1. Patient Activation Measure short form - Malay version (PAM-13-M) questionnaire
2. International Physical Activity Questionnaire - Malay version (IPAQ-M)
3. Dutch Eating Behaviour Questionnaire - Malay version (DEBQ-M)
4. Patients Assessment of Chronic Illness Care - Malay version (PACIC-M) questionnaire
5. Skala Kepuasan Interaksi Perubatan (SKIP-11) questionnaire
6. Perceived absolute 10-year CVD risk and the actual calculated risk by Framingham Risk Score (FRS) General CVD risk prediction chart.

Sample Size Determination:

Sample size is calculated using Power and Sample Size Calculation software version 3.1.2, 2014 based on the findings of a randomised controlled trial evaluating the effects of a web-based self-management intervention for adults with chronic conditions on patient activation scores, measured by the PAM-13 questionnaire. In the intervention group, the mean patient activation score at baseline was 65.33 and the mean score after the intervention was 71.30 (mean difference of 5.97 ± 9.70, t57 = 4.683, P < 0.001). Whereas, in the control group, the mean patient activation score at baseline was 66.89 and the mean score at the end of the study period was 68.93 (mean difference of 2.04 ± 10.01, t67 = 1.677, P= 0.10). Therefore, the mean difference between the two groups was 3.93.

Based on this assumption, a sample size of 97 participants per group is sufficient to detect mean difference of δ = 3.93 in the patient activation score between the two groups, with a standard deviation of σ = 9.70 using two-tailed t-test of difference between means with 80% power (power = 0.8), 5% level of significance (α = 0.05) and sample size ratio of 1:1 between the two groups (m =1). After considering a drop-out rate of 20%, the sample size required is 116 participants per group, giving a total of 232 patients to be recruited for this study.

Randomisation:

Randomisation of patients to either the EMPOWER-SUSTAIN Self-Management e-Health Intervention (I) or usual care (C) will be done using Randomised Block Design. Random allocation will be made in order to keep the sizes of the group similar. In this study, the block randomisation size will be 4 times the number of treatment arms i.e. block size of 2 by 2. With two treatment arms of the EMPOWER-SUSTAIN Self-Management e-Health Intervention (I) or usual care (C), the possible treatment allocations within each block will be as follows: IICC, ICIC, ICCI, CCII, CICI, CIIC.

Data Management:

Data will be checked before the end of each consultation to ensure the completeness of the questionnaire. If any missing data is found, the patients will be contacted again through the telephone. Raw data obtained will be entered in Excel and SPSS version 24.

Feasibility Outcomes:

Process evaluation to assess the integrity of the trial protocol will be conducted. Data to assess the integrity of the randomised controlled trial protocol will be collected. This include recruitment rate, methods of randomisation, retention rate, selection of primary/secondary outcome measures, sample size calculation, whether the intervention is delivered as intended and methods of statistical analysis to evaluate the potential effectiveness.

Statistical Analysis Plan:

The analysis will be conducted using SPSS version 24

Descriptive Analysis:

The frequency distribution, a measure of central tendency and dispersion will be produced. For the continuous data, it will be presented by mean and standard deviation or median based on the normality of the data. For the categorical data, it will be presented by absolute number and their corresponding percentages.

Effectiveness Analysis:

Intention to Treat (ITT) analysis will be applied to measure the potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention on the primary and secondary outcome measures based on the initial treatment assignment. The mixed model repeated measure analysis of variance (ANOVA) will be carried out to evaluate the potential effectiveness i.e. to compare the mean changes in patient activation, physical activity, diet, patients' chronic illness care and physician-patient interaction satisfaction scores, perceived absolute 10-year CVD risk within and between the intervention and control groups at baseline and 6-month follow-up.