Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus
NCT ID: NCT05525117
Last Updated: 2024-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-07-04
2024-12-15
Brief Summary
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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.
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Detailed Description
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The primary endpoint of this trial will be the between-groups difference of the HbA1c in the intervention and control group at six months adjusted for the baseline HbA1c. In order to show the course of change over time, two timepoints for assessment of effects are planned at four (T1) and six months (T2) after the baseline assessment (T0). The primary endpoint will be the HbA1c at six months post-allocation. Secondary endpoints will be depression, diabetes self-management (DSM), BMI, and quality of life. Figure 1 (section 6.1) summarizes the design of the clinical trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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online intervention in addition to treatment-as-usual
online intervention: covivio in addition to treatment as usual
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.
treatment-as-usual
Other: treatment as usual
treatment as usual
Participants may continue with any treatment that they require (treatment as usual)
Interventions
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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.
treatment as usual
Participants may continue with any treatment that they require (treatment as usual)
Eligibility Criteria
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Inclusion Criteria
* HbA1c value ≥ 7.0% (53 mmol/mol)
* BMI ≥ 23 kg/m2
* Consent to participate
* Sufficient knowledge of the German language
Exclusion Criteria
* change in medication, frequency of use or dosage (planned within 4 weeks before T0 or during the study period)
18 Years
75 Years
ALL
No
Sponsors
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Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Gitta Jacob, PD PhD
Role: PRINCIPAL_INVESTIGATOR
Gaia AG
Locations
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GAIA
Hamburg, , Germany
Countries
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Other Identifiers
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covivio trial 2022
Identifier Type: -
Identifier Source: org_study_id
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