The SongDance Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1C
研究概览
简要总结
Type 2 diabetes (DM2) I may be associated with low level of Quality of Life (QOL), depression, persistent stress and autonomic nervous system dysfunction (ANSD). A new biological measure measuring the Pressure Pain Sensitivity (PPS) of the chest bone has been found to be a marker for persistent stress and ANS function, and linked to depression, QOL, chronic inflammation and HbA1c. An intervention which uses the PPS measure as a biological feedback marker for stress reduces the level of persistent stress (PPS) and depression, reduces blood pressure, serum lipids, restores ANSD and increases quality of life.
Objectives: primary: if a simple individualized self-care based intervention, using the PPS of the chest bone as a biofeedback marker for stress, reduces PPS and with concomitant reduction in HbA1c. Secondly, if changes in PPS and HbA1c correlate, if the level of depression and number of clinical stress symptoms are reduced, and QOL and personal empowerment increased. Thirdly, if use of glucose-lowering medication, blood pressure, heart rate, work of the heart, autonomic nervous system dysfunction measured by PPS and cardiovascular response to tilt table test and heart rate variability, serum lipids and low-grade inflammation are reduced. As a separate part of the study, the implementation aspects of the PPS guided intervention are studied.
Design:RCT,single-blinded, 1:1 randomization, in which diabetic treatment as usual (TAU) is compared to TAU plus a self-care based intervention program based on daily PPS measurements at home over a 6 months period and daily 2 times nervestimulation as mandatory. The study will be open to the patient and the treating professionals but blinded towards the evaluating researchers. The implementation part of the study will be conducted according to WHO guidelines.
Patients: 160 patients with DM2 from primary health care. Effect variables: Primary: HbA1c. Secondary : PPS, depression, QOL, personal empowerment, and the correlation between changes in PPS and HbA1c.
Treatment: All patients receive diabetes care as usual. The active group receives in addition the self-care based, non-pharmacological PPS guided intervention program, which focuses on daily PPS measurement for cognitive reflection and cutaneous sensory nerve stimulation for reduction of PPS with the aim to reduce the elevated PPS.
详细描述
Introduction About 350 million people worldwide have type 2 diabetes (DM2). Approximately 85% of these patients are controlled in the primary health care.
A high level of personal care, i.e. high empowerment, is a pre-requisite for successful outcome of their diabetes disease. Therefore, all patients are encouraged to measure their blood glucose levels several times a week or daily, depending on the type of treatment, and to act according to the blood glucose level, typically by changing lifestyle. Several studies have shown that high empowerment increases QOL in diabetes patients. In general, living with a chronic disease is associated with low QOL, fear of the future, anxiety and depression, and similarly for patients with DM2. These elements may lead to a state of chronic stress.
The link between persistent stress on the one side, and chronic arterial inflammation and cardiovascular events recently received support from a long-term study using region brain activity as assessment for chronic stress
The PPS measure and the PPS-guided intervention Persistent stress or allostatic overload as it is also called can be measured using an algometer measuring the pressure pain sensitivity at the sternum (PPS), and the measure can be used as self-monitoring at home using daily measurements. This can then be followed by action, and thus increase the personal empowerment.
In an intervention study in healthy office workers, it was found that a reduction of an elevated PPS was significantly associated with a reduction in HbA1c, blood pressure, serum lipids, body mass index, serum YKL 40 (a marker of inflammation),and ANS dysfunction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria
- •Diagnosed DM2,
- •HbA1c: ≤ 9 % (75 mmol/mol)
- •PPS ≥ 60 units;
- •Age < 75 years;
- •Manage the Danish language for proper use of instructions,
- •Actively express to accept to conduct minimum 20 minutes of self-care daily.
排除标准
- •Use of insulin as basal-bolus regime (i,.e. the combination of long-term acting insulin as basal insulin and short-term lasting insulin as bolus injections before meals)
- •Use of Beta blockade medication
- •HbA1c > 9 % (75 mmol/mol)
- •Previously diagnosed and treated for a psychiatric disorder, except for depression.
- •A chronic competing disorder that statistically is life-shortening (such as advanced cancer with metastases).
- •A chronic competing disorder that is not heart disease and which clearly impairs the patient's quality of life /e.g. COPD, cancer, chronic pain syndrome).
- •Patients who cannot fend for themselves.
- •One or more of the following complications: diabetic retinopathy that needs specific treatment, or nephropathy (i.e. plasma creatinine ≥ 200 umol/L))
研究组 & 干预措施
active
active stress handling
干预措施: active stress handling (Device)
control
no stress handling
结局指标
主要结局
Change in Hemoglobin A1C
时间窗: 0, 3 and 6 months
numeric scale 30-150 mmol/mol; higher value indicates worsening of diabetes control
次要结局
- Correlation between changes in pressure pain sensitivity and Hemoglobin A1C(0, and 6 months)
- Personal diabetes empowerment scale (DES-ST)(0, and 6 months)
- Number of clinical stress symptoms measured by a specially designed questionnaire(0, and 6 moths)
- Depression (MDI questionnaire)(0, and 6 moths)
- Sleepiness score (Epworth)(0, and 6 months)
- pressure pain sensitivity(0, and 6 months)
- quality of life index (WHO-5)(0, and 6 months)
- Physical and mental health (SF 36)(0, and 6 moths)
- Diabetes treatment satisfaction questionnaire (DTSQ)(0, and 6 months)