Self-Care for Older People With Diabetes Mellitus (SCOPE-DM): Live Well With Diabetes Programme
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Self-efficacy assessed using the General Self-efficacy Scale
研究概览
简要总结
In Singapore, the prevalence of diabetes was approximately 12.8% in 2014 and was projected to rise to 22.7% in 2035. In 2015, the International Diabetes Federation (IDF) reported that Singapore has the second highest proportion of diabetic patients among developed nations. The impact of poorly controlled diabetes on the individual, family and health system is well known. Previous studies have shown that older persons, specifically those with chronic conditions such as diabetes, often lack sufficient knowledge about their condition and thus frequently have poor self-management skills, which is essential for good health outcome.
Health education among older persons, particularly those with chronic illnesses, has long been promoted as a priority. Chodosh and colleagues (2005) determined that there were benefits and significant improvement in blood glucose and blood pressure for chronic disease self-management programs for older adults with diabetes and high blood pressure respectively in a meta-analysis study. This project [Self-Care for Older People with Diabetes Mellitus (SCOPE-DM)] was therefore developed to help community-dwelling older patients with type 2 diabetes to effectively manage their disease by reducing diabetes-related risk factors and complications, leading to an improvement in their psychological well-being and health-related quality of life, as well as a reduction in future healthcare requirements from family and society. This study aims to investigate the effectiveness of the SCOPE-DM programme in improving the self-efficacy, motivation, medication adherence, health-related quality of life and diabetes knowledge among community-dwelling older adults with type 2 diabetes in Singapore.
This proposed study is a prospective, four-group cluster randomized controlled trial. The participants will be followed up for 6 months at the community sites and Hua Mei Clinics of the Tsao Foundation. A set of questionnaires will be used to assess participants' self-efficacy, diabetic self-care activities, health-related quality of life (HRQoL), diabetes knowledge and medication adherence. Process evaluation will also be conducted to assess the acceptability, strengths and weaknesses of the 'SCOPE-DM: Live Well with Diabetes' programme based on the participants' perspectives through the conduct of qualitative interviews.
详细描述
Overview
This study is a prospective, four-group cluster randomized controlled trial. The participants will be followed up for 6 months at the community sites or Hua Mei Clinics of the Tsao Foundation.
The 4 groups are:
i. Control group receiving routine care from their healthcare provider/ clinics of Tsao Foundation
ii. Intervention group 1 receiving the SCOPE-DM programme without supply of glucometers and accessories
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with type 2 diabetes mellitus
- •Aged 55 to 99 years old (both inclusive)
- •Community-dwelling
排除标准
- •Individuals with Type 1 diabetes mellitus
- •Unable to communicate independently in English or Mandarin
- •Mentally incapacitated individuals
结局指标
主要结局
Self-efficacy assessed using the General Self-efficacy Scale
时间窗: 6 months
Participants' level of self-efficacy is assessed using the ten-item General Self-efficacy Scale. Participants indicate their responses on a Likert scale of 1 ("Not at all true") to 4 ("Exactly true"). Scores for the ten items are then summed, with higher summed scores indicating higher levels of self-efficacy. The minimum possible summed score is 10 and the maximum possible summed score is 40. Participants in the three intervention conditions are hypothesized to have statistically significantly higher summed scores post-intervention, compared to control condition participants.
Diabetes self-care activities measured using the Revised Summary of Diabetes Self-care Activities
时间窗: 6 months
Diabetes self-care activities are assessed using a 13-item scale. Participants indicate their responses to items 1 to 12 on a scale of 0 to 7 corresponding to the number of days within the past seven days that they have performed the activities indicated. For item 13, participants indicate whether they have smoked within the past seven days, and if so, how many cigarettes on an average day. For each regimen area of general diet, exercise, blood sugar testing, footcare, and medications, the responses of the corresponding items are averaged to indicate the mean number of days, with a higher value indicating a higher level of self-care activity for the regimen area. A score of 0 is assigned to non-smoking and a score of 1 assigned to smoking, with higher scores indicating lower self-care. Participants in the three intervention conditions are hypothesized to have a statistically significantly higher level of self-care activities post-intervention, compared to control participants.
次要结局
- Proportion of participants with optimal Systolic and Diastolic Blood Pressure(6 months)
- Participants' level of knowledge of Diabetes assessed using the Revised Michigan Diabetes Knowledge Questionnaire(6 months)
- Participants' level of medication adherence assessed using Medication Adherence Report Scale(6 months)
- Proportion of participants with optimal Glycated haemoglobin Level (HbA1c Level) of 7% or lower(6 months)
- Proportion of participants with optimal Body Mass Index between 18.5 and 22.9(6 months)
- Proportion of participants who adhere to yearly eye and foot screening(6 months)
- Diabetes-specific quality of life measured using the Audit of Diabetes-Dependent Quality of Life(6 months)
- Proportion of participants with optimal levels of Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglyceride(6 months)
研究者
Raymond Boon Tar Lim
Lecturer
National University of Singapore