Lifestyle Monitoring and Coaching Using the Mobile DIAMETER Application in Secondary Care (DIAMETER-1, Phase 2 - Feasibility Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
Type 2 Diabetes Mellitus (T2DM) is a major chronic lifestyle-related disorder with a significant impact on quality and costs of care. As patients with T2DM often have insufficient knowledge about proper self-management and are insufficiently motivated for a lifestyle change, interventions with more motivational strategies and personalization are needed. The use of real-time monitoring of glucose values, nutrition and physical activity in combination with coaching aimed at lifestyle-related behavior change may improve patients' diabetes management. Therefore, ZGT, UT and RRD developed the Diameter app. The aim of phase 2 of this study is to investigate the Diameter as blended-care using a feasibility study. The primary objective of this feasibility study is to assess intervention usage and acceptability of the Diameter as a blended-care intervention in secondary care, of which some are also following a combined lifestyle intervention (GLI). Secondary objectives are to explore behavioral (e.g. physical activity), physiological (e.g. BMI), psychological (e.g. health-related quality of life) and clinical outcomes (e.g. glucose control, estimated HbA1c values).
This study has a mixed-method design with 3 (regular participants) or 4 (participants who decide to follow the Combined Lifestyle Intervention (GLI) COOL next to the Diameter during the study period) data collection points.
Patients will start with a two-week period of baseline measurements. Subsequently, patients will use the Diameter as a blended-care intervention for 10 weeks. The two-week measurement periods will be repeated twice (T1: week 13-14 and at T2: week 25-26). Between T1 and T2, patients will use a version of the Diameter without daily coaching messages. At T1 and T2, questionnaires will be administered, data on physical activity, food intake and glucose values will be logged, and blood and urine samples will be retrieved from regular care measurements. In addition, open-ended interviews will be performed with 10-15 patients at T1. For participants who also decided to follow the COOL program, some routinely collected measurements as part of the COOL program will be obtained from the patient record.
详细描述
INTRODUCTION Type 2 Diabetes Mellitus (T2DM) is a major chronic lifestyle-related disorder with a significant impact on quality and costs of care. As patients with T2DM often have insufficient knowledge about proper self-management and are insufficiently motivated for lifestyle change, interventions with more motivational strategies and personalization are needed. The use of real-time monitoring of glucose values, nutrition and physical activity in combination with coaching aimed at lifestyle-related behavior change may improve patients' diabetes management.
It is hypothesized that a technology-supported lifestyle intervention is effective and a step forward in T2DM management. In the Twente region of the Netherlands, a personalized treatment strategy to improve lifestyle in T2DM patients is being developed by providing coaching and feedback in daily life through a mobile application, the Diameter. The development of the Diameter is a collaboration between ZGT hospital, University of Twente and Roessingh Research and Development Institute. The Diameter monitors food intake, physical activity and glucose values; it gives individual patients and healthcare professionals insight into lifestyle, blood glucose levels, as well as into the effect of lifestyle behavior on glucose values in daily life. Furthermore, the Diameter offers evidence-based coaching aimed at improving lifestyle, i.e. physical activity and nutrition. The coaching content offered in the Diameter comprises the e-supporter which is developed by the UT, ZGT and TNO within the E-Manager project. It consists of goal setting, daily lifestyle coaching via short messages and a weekly exercise that supports people to achieve selected goals for a period of ten weeks. An innovative and unique coaching strategy is the feedback on blood glucose levels through continuous glucose monitoring (i.e., FreeStyle Libre). This continuous feedback is considered to be a very powerful tool for behavior modification and offers great potential. The development of the Diameter is an iterative process. Since 2017, the monitoring and coaching elements of the Diameter have been developed, extended and validated in several studies. In a blended-care setting, the Diameter combines face-to-face counselling of usual T2DM care with the Diameter and continuous glucose monitoring through the FreeStyle Libre.
OBJECTIVE The Diameter as a blended-care intervention has only been evaluated in a small pilot study (phase 1) in ZGT hospital to test the proposed research protocol for phase 2 with T2DM patients treated at the outpatient clinic. Therefore, information about the intervention usage and acceptability are not yet available, as well as proper data for sample size calculation in future effectiveness testing. The next step is to implement and evaluate the Diameter in practice regarding intervention usage and acceptability (e.g. effort expectancy, pleasure), and to explore its effect on clinical outcomes (e.g. glycemic control), physiological (e.g. body composition), behavioural (e.g. physical activity), and psychological outcomes (e.g. health-related quality of life). Phase 2, which is registered in this trial system, concerns a feasibility study in ZGT hospital to evaluate intervention usage and acceptability of the Diameter as part of usual care. Usual care includes traditional diabetes care, possibly for a subgroup of participants, supplemented by the combined lifestyle intervention "Gecombineerde Leefstijl Interventie" (GLI) COOL which will be offered by ZGT to their T2DM patients.
STUDY DESIGN The Diameter will be assessed using a mixed-methods prospective longitudinal design among 80 patients with T2DM. Approximately 20-40 of them will also follow the COOL program as part of usual care. During the study, 3 rounds of measurement will be performed. Additionally, for participants who started the COOL program next to the use of the Diameter, an extra measurement moment after 8 months (T3) is included. The data for this measurement will be collected as part of usual care and will be extracted from the participants' health record with the patients' consent.
The measurements will be performed at the following time points:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The primary study aim is to assess intervention usage and acceptability (e.g. effort expectancy, pleasure) regarding the Diameter integrated in regular secondary care and how acceptability is associated with intervention usage. Therefore, the study does not make use of a double blind randomized controlled trial as this design does not fit the study's primary purpose. Consequently, there will be no randomization and treatment allocation. To minimize the treatment effect at baseline, baseline measures will be blinded as much as possible, i.e., participants will not be able to get insight in their glucose values and nutrient intake. The physical activity data collected with the Fitbit cannot be blinded, so that the participants do have insight into their physical activity during the baseline measurements
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
- •Diagnosed with type 2 diabetes mellitus
- •Being familiar with using a smartphone
- •Being treated in ZGT hospital or primary care
排除标准
- •Dependence on renal replacement therapy
- •Severe general diseases or mental disorders make the participation in the study impossible
- •Insufficient mastery of the Dutch language
- •Other CGM device than Freestyle Libre.
结局指标
主要结局
Acceptability
时间窗: T1 (week 13-14)
Acceptability will be assessed using an UTAUT2 questionnaire of 19 questions. The UTAUT2 determinants include performance expectancy, effort expectancy, pleasure/hedonic motivation, facilitating circumstances, design, technical issues and habit. The experiences with the Diameter will be assessed using multiple statements generated by the research team according to literature and previous used UTAUT2-model based questionnaires. Each statement will be scored on a 7-point Likert scale (1 = extremely disagree, 7 = extremely agree) where a higher score indicate positive experiences with the Diameter. The scores will be used to calculate individual sum scores per determinant of the UTAUT2 model. Open-ended interviews will be conducted with a subset of 10-15 participation to gain in-depth information on the acceptability, and perceived barriers and facilitating conditions for usage of the Diameter.
Intervention usage - frequency
时间窗: T1 (week 13-14)
The way in which the intervention is actually used in terms of frequency (number of time used over time)
Intervention usage - duration
时间窗: T1 (week 13-14)
The way in which the intervention is actually used in terms of duration (minutes of use over time)
次要结局
- Glycemic regulation - Time In Range (TIR)(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Body Mass Index(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Body composition(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Glucose-lowering medication usage(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- T2DM-related medication usage(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Glycemic regulation - eHbA1c(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- eGFR(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Albumin/creat ratio(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Self-efficacy(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Glycemic regulation - Time Below Range (TBR)(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Glycemic regulation - Time Above Range (TAR)(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- HDL-cholesterol(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Creatinine(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Nutritional behavior(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Waist and hip circumference(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- HbA1c(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Fasting glucose(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Blood pressure(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Peripheral neuropathy(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Amputations(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Physical activity(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Self-management(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Health-related quality of life(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Total cholesterol(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- LDL-cholesterol(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Triglycerides(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Albumin(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Handgrip strength(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Ulcers(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Stages of change(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
- Treatment adherence(T0 (baseline), T1 (week 13-14), T2 (week 25-26))
研究者
Eclaire Hietbrink
Principal Investigator
University of Twente