The SongDanceT1 Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment.
NCT06087679 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2023-10-30
Summary
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:
1. 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?
Conditions
- Autonomic Dysfunction
- Stress, Psychological
Interventions
- BEHAVIORAL
-
PPS guided selfcare based intervention program
Guided selfcare programme (Please refer to project description)
Sponsors & Collaborators
-
Department of Medicine, Endocrine Unit Herlev University Hospital, Herlev, Denmark
collaborator UNKNOWN -
Steno Diabetes Center Copenhagen
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-08
- Primary Completion
- 2024-01-30
- Completion
- 2024-02-01
Countries
- Denmark
Study Locations
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