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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087679 on ClinicalTrials.gov