TeleCare North Diabetes: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Experiences with and acceptability of intervention design(s)
研究概览
简要总结
This feasibility study will evaluate the feasibility of two telemonitoring designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.
详细描述
Background: Maintaining optimal glycaemic control in type 2 diabetes (T2D) is difficult. Telemedicine has potential to support poorly controlled people with T2D in the achievement of glycaemic control if the telemedicine solution includes a telemonitoring component. However, only few telemonitoring solutions for non-insulin treated T2D exist. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring intervention designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.
Method: The trial will be conducted as a three-month randomized feasibility study in four municipalities in North Denmark with 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, differences in direct intervention costs between the two alternative interventions will be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men ≥ 18 years
- •Poorly controlled T2D, i.e. HbA1c > 58 mmol/mol
- •Diagnosis of T2D for at least 12 months
- •General Practitioner responsible for diabetes treatment
- •Residence in Hjørring, Morsø, Jammerbugt, or Rebild municipality
- •Ability and willingness to use a smartphone/tablet along with the other devices to be used in the trial
- •Signed informed consent
- •Ability to understand and read Danish
排除标准
- •Pregnancy or breastfeeding
- •Insulin treatment
- •Prednisolone treatment
- •Severe diabetes complications such as severe neuropathy or nephropathy (dialysis treatment)
- •Participation in diabetes rehabilitation courses
- •Participation in other intervention trials
- •Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate
结局指标
主要结局
Experiences with and acceptability of intervention design(s)
时间窗: 3 months
Qualitative interviews will be conducted with selected participants and HCPs to gain deeper insight into the participants and HCPs' experiences and acceptability with the two different telemonitoring intervention designs and the trial procedures.
次要结局
- Retention assessment 1(3 months)
- Adherence to answering the questionnaire: Well-being: The World Health Organization Five Well-being Index (WHO-5)(At baseline (T0) and 3 months (T1))
- Feasibility of the recruitment assessment 1(1 month)
- Retention assessment 4(3 months)
- Challenges in the blood sampling schedule(At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3))
- Costs(12 months)
- Feasibility of the recruitment assessment 2(1 month)
- Feasibility of the recruitment assessment 3(1 month)
- Feasibility of the recruitment assessment 5(1 month)
- Adherence to the blood sampling schedule(At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3))
- Feasibility of the recruitment assessment 4(1 month)
- Retention assessment 2(3 months)
- Retention assessment 3(3 months)
- Retention assessment 5(3 months)
- Adherence to answering the questionnaire: The Patient Activation Measure questionnaire (PAM)(At baseline (T0) and 3 months (T1))
- Adherence to answering the questionnaire: Diabetes-related quality of life: The Problem Areas in Diabetes Questionnaire (PAID-5)(At baseline (T0) and 3 months (T1))
- Adherence to answering the questionnaire: Quality of Life: The Short Form 12 Questionnaire (SF-12v2)(At baseline (T0) and 3 months (T1))
研究者
Peter Vestergaard
MD, professor
Aalborg University Hospital