The SongDanceT1 Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment. An Implementation Study Combined With an Observer-blinded Randomized Controlled Interventional Trial (SongDance T1D)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- change in resting PPS
研究概览
简要总结
In an implementation study, designed as a RCT in people with type 1 diabetes(T1D) and an elevated Pressure pain sensitivity of the chest bone(PPS) as indicative of dysfunction of the autonomic nervous system (ANSD), to describe the effect of a selfcare programe on the following outcome measures:
- PPS, and the effect on health risk factors associated to quality of life, physiology and metabolism.
People acceptance of the program: Can T1D people comply with the program and integrate the program into their daily life? 2. The professional staff acceptance of the program: Does the staff comply to the program and does the program comply to the routines of the clinical department?
详细描述
Type 1 Diabetes is a chronic disease, affecting mostly young people and associated with depression among approx. 20-25% of the people.
Depression in T1D is further associated with a poor treatment adherence, hyperglycemia, increased health costs, increased complications, cognitive decline, and also increased all-cause and coronary heart disease mortality.
Besides the 3 classical complications to T1D, retinopathy, nephropathy and neuropathy, dysfunction of the autonomic nervous system (ANSD) is often seen, and is regarded as a complication to long standing T1D. The latter is typically tested as impairment of autonomic control of the cardiovascular system and is designated cardiac autonomic neuropathy (CAN). The prevalence is approx. 15% of definite ANSD (higher when including incipient ANSD) and depending on the duration of the diabetes disease.
Autonomic nervous system dysfunction is in general associated to chronic stress, depression, and reduced quality of life (QOL). In people with ischemic heart disease (IHD), it is associated to increased morbidity and mortality. In T1D, ANSD is associated with increased morbidity, especially cardiovascular disease, kidney disease and peripheral neuropathy.
Pressure pain sensitivity of the chest bone (PPS), usually measured by a special algometer (StressMeter), was originally found to be associated to acute and chronic stress. However, recent studies have found a close association between chronic stress and ANSD, linking these two together (for review see www.stressmeter.org). PPS seems to measure primarily sympathetic autonomic function, probably in the brain, and potentially at the level of the lateral hypothalamus. As such, resting PPS seems to be indicative of autonomic function.
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
- Single (Care Provider)
盲法说明
The participants are randomized 1/1: active/control, and a person, who has no direct contact to the participants, performs the randomization. The study is open to the participating participants and the instructors of the active group. The study is blinded to all others, including the statisticians who make the main analyses.
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
- •Diagnosed T1D
- •BMI < 40
- •PPS ≥ 60 arbitrary units (normal range: 30 - 60)
- •Age < 75 years; age ≥ 18 years
- •Manage the Danish language for proper use of instructions,
- •Actively accepting to conduct a minimum of 20 minutes of self-care daily according to the ULLCARE program.
排除标准
- •Use of Beta blockade medication, and tricyclic anti-depressive medication
- •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 not a diabetes co-morbidity, which clearly impairs the participant's QOL /e.g. COPD, cancer, chronic pain syndrome).
- •People who cannot conduct the selfcare program (example: having one arm, only)
结局指标
主要结局
change in resting PPS
时间窗: Measured at baseline and 6-months follow-up
A StressMeter® (UllCare A/S, Hellerup, Denmark) is a device that measure the ammount of pressure applied to the skin. Participants will apply presure on specific pressure point (describe in the project description) and read an abitrary number of pressure og a display when dyscomfort is felt.
次要结局
- Resting heart rate variability indices (HRV)(Measured at baseline and 6-months follow-up)
- Resting pulse(Measured at baseline and 6-months follow-up)
- Major depression inventory (MDI)(Measured at baseline and 6-months follow-up)
- Total CAN score (Vagus®)(Measured at baseline and 6-months follow-up)
- Resting Blood pressure(Measured at baseline and 6-months follow-up)
- cardiovascular response to a tilt table test(Measured at baseline and 6-months follow-up)
- Epworth Sleepiness score(Measured at baseline and 6-months follow-up)
- special designed questionnaire with focus on sleep disturbance(Measured at baseline and 6-months follow-up)
- Diabetes treatment satisfaction questionnaire (DTSQ)(Measured at baseline and 6-months follow-up)
- diabetes empowerment, measured by the questionnaire DES-SF(Measured at baseline and 6-months follow-up)
- WHO-5 quality of life score(Measured at baseline and 6-months follow-up)
- PPS response to a tilt table test(Measured at baseline and 6-months follow-up)
- The three individual CAN score tests (CARTs)(Measured at baseline and 6-months follow-up)
- Implementation study questionnaire according the WHO guidelines(Measured at baseline and 6-months follow-up)
- Clinical stress sign score (CSS)(Measured at baseline and 6-months follow-up)
- Problem Areas In Diabetes (PAID-20)(Measured at baseline and 6-months follow-up)