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
试验速览
- 阶段
- 不适用
- 入组人数
- 232
- 主要终点
- The mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM 13-M) questionnaire.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with MetS according to the JIS definition
- •have received follow-up care for MetS at the university primary care clinic at least twice in the last one year
- •have regular access to the internet
- •perceive that they have basic skills to use the web and smart mobile phone
- •are able to read and understand written English or Malay
排除标准
- •type 1 diabetes mellitus
- •receiving renal dialysis
- •resented with severe hypertension (Systolic BP > 180 mmHg and/or Diastolic BP > 110 mmHg) at recruitment
- •diagnosed with conditions resulting in secondary hypertension
- •diagnosed with circulatory disorders requiring referral to secondary care over the last one year and during the course of the study
- •receiving shared care at primary and secondary care centres for cardiovascular diseases
- •receiving chemotherapy/ radiotherapy or palliative care
- •diagnosed with a psychiatric illness such as schizophrenia, bipolar disorder, major depression
- •diagnosed with cognitive impairment such as dementia
- •enrolled in another intervention study
结局指标
主要结局
The mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM 13-M) questionnaire.
时间窗: 6 months
The PAM-13 consists of 13 items measuring patients' self-reported knowledge, skills and confidence for self-management. Each item is scored on a Likert scale of 1-5. The instrument reflects the 4 stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important), level 2 (patients have confidence and knowledge to take action), level 3 (taking action) and level 4 (staying on course under stress). According to the scoring guidelines, the raw scores are transformed through natural logarithm to achieve a better expression of the relative distance between the scores. Then, items are transformed to a standardized metric ranging from 0 to 100 (0 = lower activation; 100 = highest activation). The score is calculated by summing up the raw scores and mapping up the sum onto a scale of 0-100. A higher score of PAM-13 indicates a high level of patients activation.
次要结局
- Change in physical activity level using the International Physical Activity Questionnaire short form Malay version (IPAQ-M)(6 months)
- Change in eating behaviour will be measured by the Dutch Eating Behaviour Questionnaire - Malay version (DEBQ-M)(6 months)
- Change in patients' perceptions and experiences of receiving care for chronic conditions will be measured by the Patients Assessment of Chronic Illness Care Malay version (PACIC-M) questionnaire(6 months)
- Change in patient-physician satisfaction will be measured by the the Skala Kepuasan Interaksi Perubatan (SKIP 11) questionnaire(6 months)
- Change in the accuracy of the Perceived Absolute 10-year CVD Risk(6 months)
研究者
Professor Dr. Anis Safura Ramli
Professor
Universiti Teknologi Mara