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Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus

NCT05525117 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-05-28

No results posted yet for this study

Summary

This trial was designed to evaluate the effectiveness of the dialogue-based online intervention covivio, which was designed to improve diabetes self-management in patients with type 2 diabetes.

The study aims to test the hypothesis that covivio has a greater positive impact on glycemic control than treatment as usual. Patients with type 2 diabetes mellitus will be randomized and allocated to either an intervention group, receiving covivio in addition to treatment as usual, or a control group, which receives only treatment as usual. The primary endpoint is the HbA1c value six month after baseline.

Conditions

Interventions

BEHAVIORAL

covivio (additional to treatment as usual)

Covivio is a dialogue-based online psychological intervention for patients with type 2 diabetes. This intervention includes elements that address disease literacy, physical activity and exercise, dieting and nutritional principles, coping with depression, etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual treatment.

OTHER

treatment as usual

Participants may continue with any treatment that they require (treatment as usual)

Sponsors & Collaborators

  • Gaia AG

    lead INDUSTRY

Principal Investigators

  • Gitta Jacob, PD PhD · Gaia AG

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
2023-07-04
Primary Completion
2024-07-15
Completion
2024-12-15

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT05525117 on ClinicalTrials.gov