iSMS: Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The aim of this study is to develop and evaluate a person-centred digital intervention in primary healthcare for people with T2D, in addition to their usual diabetes care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes within the last five years
- •18 years of age or older
- •Ability to read and communicate in Swedish
- •Own a smart phone
排除标准
- •81 years and over at inclusion
- •Life-threatening physical illness (e.g. cancer)
- •Documented cognitive impairment
- •Those not responsible for their own self care
- •Those not residing in their own home environment (e.g. those in nursing homes, in-patient hospital wards)
研究组 & 干预措施
Intervention arm
Participants in the intervention group will receive usual care, and also use a diabetesapp and a homepage and advice personally tailored according to the personal needs to provide support for them to manage e.g. food choices, exercise, medicine, blood sugars and emotional adaptation.
干预措施: Intervention arm: Person-centred interactive self-management support (Behavioral)
Control arm
Participants in the control group will receive usual care and also take part in a minimal intervention in the form of a brochure on the importance of self-management in diabetes.
干预措施: Control arm (Other)
External comparison group
An external comparison group will be recruited from two other primary health care centers in order to analyse possible Hawthorne effects.
干预措施: External comparison group (Other)
结局指标
主要结局
HbA1c
时间窗: Baseline, 6 months, and 12 months
Change from baseline in HbA1c at 6 months and 1 year (in mmol/mol)
次要结局
- Lifestyle habits - smoking(Baseline, 6 months, and 12 months)
- Medical treatment(Baseline, 6 months, and 12 months)
- Illness perception(Baseline, 6 months, and 12 months)
- Systolic blood pressure(Baseline, 6 months, and 12 months)
- Diabetes-dependent QoL(Baseline, 6 months, and 12 months)
- Body Mass Index(Baseline, 6 months, and 12 months)
- Waist circumference(Baseline, 6 months, and 12 months)
- Cholesterol, total, LDL and HDL(Baseline, 6 months, and 12 months)
- Diabetes empowerment(Baseline, 6 months, and 12 months)
- eHealth literacy(Baseline, 6 months, and 12 months)
- Lifestyle habits - physical activity(Baseline, 6 months, and 12 months)
- Lifestyle habits - diet(Baseline, 6 months, and 12 months)
研究者
Ulrika Öberg
MSc, PhD student
Umeå University