Ignite Creation Date:
2024-05-06 @ 1:47 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04120779
Status:
UNKNOWN
Last Update Posted:
2020-11-23
First Post:
2019-10-04
Brief Title:
Study Protocol of the EMPOWER-SUSTAIN Project
Sponsor:
Universiti Teknologi Mara
Organization:
Universiti Teknologi Mara
Study Overview
Official Title:
Study Protocol of the EMPOWER-SUSTAIN Project A Pilot Randomised Controlled Trial of e-Health Intervention to Improve Patient Activation and Self-Management Behaviours Among Individuals With Metabolic Syndrome in Primary Care Setting
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pilot randomised controlled trial will be conducted in UiTM Primary Care Clinic Selayang Campus Selangor Malaysia A total of 232 patients with Metabolic Syndrome MetS will be recruited 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months and another 116 patients will continue with usual care The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategies based on the Chronic Care Model 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 The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version PAM-13-M questionnaire The secondary outcomes include the change in patients physical activity level eating behavior patients perception on chronic illness care satisfaction in physician-patient interaction and perceived absolute 10-year cardiovascular disease CVD risk
Detailed Description:
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
I Waist Circumference WC M 90 cm F 80 cm South Asian cut-points II Blood Pressure BP Systolic BP 130 andor diastolic BP 85 mmHg or on treatment for hypertension HPT III Fasting Blood Glucose FBG 56 mmolL or on treatment for elevated glucose IV Triglycerides TG 17 mmolL or on treatment for TG V High density lipoprotein cholesterol HDL-c Male 10 mmolL Female 13 mmolL 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 eg 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 patients 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 312 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 6533 and the mean score after the intervention was 7130 mean difference of 597 970 t57 4683 P 0001 Whereas in the control group the mean patient activation score at baseline was 6689 and the mean score at the end of the study period was 6893 mean difference of 204 1001 t67 1677 P 010 Therefore the mean difference between the two groups was 393
Based on this assumption a sample size of 97 participants per group is sufficient to detect mean difference of δ 393 in the patient activation score between the two groups with a standard deviation of σ 970 using two-tailed t-test of difference between means with 80 power power 08 5 level of significance α 005 and sample size ratio of 11 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 ie 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 primarysecondary 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 ie 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
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
I Waist Circumference WC M 90 cm F 80 cm South Asian cut-points II Blood Pressure BP Systolic BP 130 andor diastolic BP 85 mmHg or on treatment for hypertension HPT III Fasting Blood Glucose FBG 56 mmolL or on treatment for elevated glucose IV Triglycerides TG 17 mmolL or on treatment for TG V High density lipoprotein cholesterol HDL-c Male 10 mmolL Female 13 mmolL 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 eg 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 patients 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 312 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 6533 and the mean score after the intervention was 7130 mean difference of 597 970 t57 4683 P 0001 Whereas in the control group the mean patient activation score at baseline was 6689 and the mean score at the end of the study period was 6893 mean difference of 204 1001 t67 1677 P 010 Therefore the mean difference between the two groups was 393
Based on this assumption a sample size of 97 participants per group is sufficient to detect mean difference of δ 393 in the patient activation score between the two groups with a standard deviation of σ 970 using two-tailed t-test of difference between means with 80 power power 08 5 level of significance α 005 and sample size ratio of 11 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 ie 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 primarysecondary 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None