Effectiveness of Advance Health Mobile APP for the Self Management of Diabetes Type2 in a Resource-constrained Setting, a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Diabetes Self-Management
研究概览
简要总结
Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.
详细描述
Patients with type 2 diabetes may experience improvements in their blood glucose levels thanks to mHealth technologies like mobile apps and telehealth text messaging. The goal of this intervention is to help diabetic people better control their blood glucose levels and diabetes. The intervention arm will employ a smartphone application designed specifically for individuals with Type 2 diabetes, with the goal of improving their self-management behaviors. Features of the app include real-time health monitoring, appointment scheduling, medication tracking, patient data storage, treatment and follow-up recommendations, and health education and promotion.
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
- Double (Participant, Investigator)
盲法说明
Participants and Investigators are blinded.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of T2D and at least 1 recorded HbA1c level of 8.0% or higher in the past 6 months
- •Age between ages 21 and 85 years,
- •Receiving primary care at the clinical site
- •Having fluency in English/ Urdu in reading and writing
- •Having a smartphone
- •Agreeing to take part in the study
排除标准
- •Planning to move away from the study site
- •Being pregnant or in lactation, (6) being unable to send or read text messages on a mobile phone,
- •Having a history of receiving or planning surgery.
结局指标
主要结局
Diabetes Self-Management
时间窗: 6- months from baseline
DSMQ-R will assess Diabetes self-management. The DSMQ-R is a multidimensional questionnaire with 27 items regarding essential self-management practices for T1D and T2D (including diabetes-adjusted eating, glucose testing/monitoring, medication taking, physical activity, and cooperation with the diabetes team). 4 Subscales: * 'Glucose Management' (GM), 11 items: 1, 4, 6, 10, 12, 21, 22, 23, 24, 26, 27 (10 and 12 must be inverted). * 'Dietary Control' (DC), 7 items: 2, 5, 9, 13, 17, 18, 25 (5, 13 and 18 must be inverted). * 'Physical Activity' (PA), 3 items: 8, 11, 15 (11 and 15 must be inverted). * 'Health-Care Use' (HU), 4 items: 3, 7, 14, 19 (7 and 14 must be inverted). SCALE SCORE = ACTUAL SUM OF ITEMS / MAXIMUM POSSIBLE SUM OF ITEMS x 10
次要结局
- Hemoglobin A1C(6- months from baseline)
- Adherence to medication(6- months from baseline)
- Health related quality of life(6- months from baseline)
研究者
Arshed Muhammad
PhD
Universiti Putra Malaysia