The PACT (Patient Activation Through Conversations) Study - A Cluster Randomised Trial of a Health Coach-led Patient Activation Program in Type 2 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 432
- 试验地点
- 6
- 主要终点
- HbA1c
研究概览
简要总结
The PACT Study is a cluster randomised trial of a health coach-led patient activation program in type 2 diabetes. The goal of this clinical trial is to evaluate the effectiveness of a health coaching intervention (PACT program) led by Care Coaches (trained lay persons), in adult participants with sub-optimally controlled Diabetes Mellitus, as compared to participants undergoing routine care for diabetes (Usual Care).
The primary outcome of interest is change in Glycated Haemoglobin (HbA1c) levels over 3 months, 6 months and 12 months. Secondary outcomes include changes in blood pressure, low-density lipoprotein-cholesterol (LDL-C) levels, body mass index (BMI), self-reported diabetes self-care behaviours, self-efficacy, health-related quality of life, and diabetes-related distress, over 3, 6 and 12 months.
Participants in the Intervention arm will undergo the PACT Program, which is a 3-month long health coaching program led by a care coach. Participants review their motivators, health parameters, self-care behaviours, and set goals for improving their diabetes using a PACT report. Subsequently, they will receive fortnightly motivational and problem solving support via telephone or WhatsApp messaging over a 3-month duration, and will return to routine care after 3 months. Participants in the Usual Care arm will have routine care of their diabetes treatment.
详细描述
Study Methodology
This is a cluster randomised controlled trial comparing the PACT program to Usual Care. Each cluster consists of a Teamlet in a NHG Polyclinic, consisting of a regular group of Family Physicians, a Care Manager, and a Care Coordinator, that provide chronic care for a regular group of about 5000 patients.
Study Population
The study population will include patients with suboptimal control of diabetes (HbA1c >8%) between the ages of 21 to 64. Patients with a suboptimal control of diabetes frequently require a combination of both pharmacological and lifestyle measures for improvement of their glycaemic levels.
The inclusion criteria include the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a diagnosis of Type 2 Diabetes Mellitus who are enrolled in Teamlets in NHGP
- •Age between 21 to 64 years old
- •HbA1c level of more than 8% in the last 6 months
排除标准
- •History of acute coronary syndrome in the past 3 months
- •History of stroke or transient ischaemic attacks in the past 3 months
- •History of end stage organ failure (liver cirrhosis, cardiac failure, latest eGFR <30 mL/min/1.73m2 in the last 6 months)
- •Cancer requiring treatment in the past 5 years.
- •Active psychiatrist follow up
- •Social issues that are significant enough for follow-up or referral with a medical social worker within the last 12 months
- •Women who are pregnant or breastfeeding
- •Patients who are enrolled in other current diabetes-related interventional studies
- •Inability to provide written consent for the study protocol and able to commit to the study duration.
结局指标
主要结局
HbA1c
时间窗: 24 Months
Glycated Hemoglobin
次要结局
- Adverse events(12 months)
- Drugs Prescribed(24 months)
- Diabetes Empowerment Scale (DES-SF)(12 months)
- eGFR(24 months)
- LDL-C(24 months)
- EuroQol group 5-Dimension 5-Level Scale (EQ-5D-5L)(12 months)
- BMI(24 months)
- Blood Pressure(24 months)
- uACR(24 months)
- Referral to community exercise programs(12 months)
- 2-item Diabetes Distress Scale (DDS-2)(12 months)
- 5 questions from the Patient Satisfaction Questionnaire-III(3 months)
- uPCR(24 months)
- Summary of Diabetes Self-Care Activities Scale (SDSCA)(12 months)
- CollaboRATE scale.(3 months)
- Costs and resource utilisation(24 months)