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The SongDance Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment 160 At-Home

Unknown status
Clinical Trial NCT03576430 (SongDance) is an interventional study for Diabetes Mellitus, Type 2, Stress that is unknown status. It started on May 31, 2018 with plans to enroll 160 participants. Led by Herlev Hospital, it is expected to complete by February 28, 2020. The latest data from ClinicalTrials.gov was last updated on July 15, 2019.
Brief Summary
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 m...Show More
Detailed Description
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 treatmen...

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Official Title

The SongDance Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment

Conditions
Diabetes Mellitus, Type 2, Stress
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • SongDance
  • H-17034836
NCT ID Number
NCT03576430
Start Date (Actual)
2018-05-31
Last Update Posted
2019-07-15
Completion Date (Estimated)
2020-02-28
Enrollment (Estimated)
160
Study Type
Interventional
PHASE
N/A
Status
Unknown status
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active Comparatoractive
active stress handling
active stress handling
biofeed back stress handling
No Interventioncontrol
no stress handling
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Hemoglobin A1C
numeric scale 30-150 mmol/mol; higher value indicates worsening of diabetes control
0, 3 and 6 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
pressure pain sensitivity
numeric scale, range 30-100; higer values indicate more stressed person
0, and 6 months
Correlation between changes in pressure pain sensitivity and Hemoglobin A1C
see above, numeric scale; range 0-1, higher correlation indicates higher association between mean bood glucose and stress
0, and 6 months
Personal diabetes empowerment scale (DES-ST)
4 questions, range 1-5, sum score, numeric scale range 4-20; higher values indicate higher empowerment
0, and 6 months
quality of life index (WHO-5)
5 questions, sum score, numeric scale, range 0-25, higher values indicate better quality of life
0, and 6 months
Physical and mental health (SF 36)
quality of life, 11 questions, sum score, numeric scale, range 0 - 100; higher values indicate better Physical and mental health
0, and 6 moths
Depression (MDI questionnaire)
depression symptoms, 10 questions, range 0-6, sum score, numeric scale, range 0-60; higher values indivate more depressed person
0, and 6 moths
Number of clinical stress symptoms measured by a specially designed questionnaire
Number of stress symptoms, sum of 56 questions, numeric scale; range 0-56, higher values indicate more stressed person
0, and 6 moths
Sleepiness score (Epworth)
8 questions, range 0-3, sum score, numeric scale; range 24; higher values indicate increased tiredness
0, and 6 months
Diabetes treatment satisfaction questionnaire (DTSQ)
treatment satisfaction: 8 questions, range 0-6, sum score; range 0-48, the higher the more satisfied
0, and 6 months
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

Inclusion criteria

  • Diagnosed DM2,
  • HbA1c: ≤ 9 % (75 mmol/mol)
  • BMI < 40.
  • 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.

  • 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))
Herlev Hospital logoHerlev Hospital
Study Responsible Party
Jens Faber, Principal Investigator, professor, Herlev Hospital
No contact data.
1 Study Locations in 1 Countries
Department of Medicine, Herlev Hospital, Herlev, 2730, Denmark