A Randomised Controlled Trial on a Nurse-led Smartphone-based Self-management Programme for Type 2 Diabetes Patients With Poor Glycaemic Control
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 主要终点
- Self-efficacy: change is being assessed
研究概览
简要总结
Aim. To develop and compare a nurse-led smartphone-based self-management programme with an existing nurse-led diabetes service on health-related outcomes of type 2 diabetes patients with poor glycaemic control in Singapore.
Background. Over the past decades, Asia has emerged as the 'diabetes epicentre' in the world due to rapid economic development, urbanisation, and nutrition transition. There is an urgent need to develop more effective care management strategies in response to this rising diabetes epidemic.
Design. A randomised controlled trial with pre- and repeated post-tests control group design.
Methodology. A total of 128 type 2 diabetes patients with poor glycaemic control will be recruited from the diabetes clinic of a public acute hospital in Singapore through convenience sampling. Study participants will be randomly allocated either to the experimental group or the control group. Outcome measures will include the 10-item General Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities, and 19-item Diabetes-Dependent Quality of Life. Data will be collected at three time points: baseline, 3 months, and 6 months from the baseline.
Discussion. It is expected that this programme will be an alternative offered to diabetes patients to master their self-care management skills, in addition to the existing diabetes service provided in diabetes clinics in Singapore hospitals. Furthermore, the self-supporting and less resource-intensive nature of this programme, through the use of a smartphone application as the mode of intervention delivery, will greatly reduce nurses' direct contact time with patients and allow more time to be allocated to those who require more attention.
详细描述
Specific Aims
The aims of this study are:
- to develop a nurse-led smartphone-based self-management programme (NSSMP) for patients with type 2 diabetes;
- to compare the NSSMP with an existing nurse-led diabetes service (NDS) on self-efficacy, diabetes self-care activities, health-related quality of life (HRQoL), glycaemic control, acute diabetes complications (e.g. hypoglycaemia, Diabetic Ketoacidosis [DKA] and Hyperosmolar Hyperglycemic Syndrome [HHS]), and health-service use among type 2 diabetes patients with poor glycemic control in Singapore.
Study Hypotheses
Study participants will be randomized into an existing NDS group (i.e. control group) and a newly developed NSSMP group (i.e. experimental group). It is hypothesized that participants in the NSSMP group as compared with participants in the NDS group will have significantly:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have confirmed medical diagnosis of type 2 DM;
- •are 21 years old and above;
- •have blood test result of HbA1c > 8% in the most recent test indicating poor glycemic control;
- •possess and able to use smart mobile phone (e.g. Samsung Galaxy, iPhone) in their daily lives; and
- •are able to speak and read English or Chinese.
排除标准
- •have suffered severe complications such as severe stroke, visual impairment, renal failure that interfere with self-care activities;
- •have known history of major psychiatric illness;
- •have reading and hearing difficulties.
结局指标
主要结局
Self-efficacy: change is being assessed
时间窗: Change from baseline self-efficacy at 6 months
Self-efficacy will be assessed using the General Self-efficacy Scale (GSS), a 10-item questionnaire of the unidimensional measure of one's competence to deal with the challenging events encountered in various life situations
次要结局
- Visits to the emergency(at the 6-month of the study period)
- Diabetes self-care activities: change is being assessed(Change from baseline diabetes self-care acitivities at 6 months)
- Health-related Quality of Life: change is being assessed(Change from baseline health-related quality of life at 6 months)
- Acute Diabetes Complications: change is being assessed(Change from baseline acute diabetes complications at 6 months)
- HbA1c: change is being assessed(Change from baseline HbA1c at 6 months)
- Smoking status: change is being assessed(Change from baseline smoking status at 6 months)
- Alcohol consumption: change is being assessed(Change from baseline alcohol consumption at 6 months)
- Diabetes-related hospital admission(at the 6-month of the study period)
- Unplanned medical consultation(at the 6-month of the study period)
研究者
Wang Wenru
Principal Investigator
National University of Singapore