The SongDanceT1 Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment.

NCT06087679 | Unknown DMC

• 1 other identifier: 72976
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 1.PPS, and the effect on health risk factors associated to quality of life, physiology and metabolism.
2. 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

Outcome Measures

Primary Outcomes (1)

• change in resting PPS

  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.

  Measured at baseline and 6-months follow-up

Secondary Outcomes (16)

• Total CAN score (Vagus®)

  Measured at baseline and 6-months follow-up

• The three individual CAN score tests (CARTs)

  Measured at baseline and 6-months follow-up

• Resting heart rate variability indices (HRV)

  Measured at baseline and 6-months follow-up

• Resting pulse

  Measured at baseline and 6-months follow-up

• Resting Blood pressure

  Measured at baseline and 6-months follow-up

Other Outcomes (9)

• Number of sick leave days (for people at work)

  Number of sick days between baseline and 6-months follow-up

• Total number of elevated health risk factors

  Measured at baseline and 6-months follow-up

• HbA1c

  Measured at baseline and 6-months follow-up

Study Arms (2)

Selfcare program

EXPERIMENTAL

6-month intervention period with a PPS guided selfcare based intervention program

Behavioral: PPS guided selfcare based intervention program

Control group

NO INTERVENTION

Treatment as usual

Interventions

PPS guided selfcare based intervention program BEHAVIORAL

Guided selfcare programme (Please refer to project description)

Also known as: ULLCARE

Selfcare program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Department of Medicine, Endocrine Unit Herlev University Hospital, Herlev, Denmark: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Primary Dysautonomias; Stress, Psychological

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center parallel placebo-controlled randomized trial

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: October 18, 2023
• Study Start: July 8, 2022
• Primary Completion: January 30, 2024
• Study Completion: February 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)