An interventional study of covivio (additional to treatment as usual) and treatment as usual in Type 2 Diabetes, sponsored by Gaia AG. Withdrawn at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Gaia AG · Not applicable, Interventional, and Treatment
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.
The aim of this clinical trial is to investigate the effectiveness of the self-guided digital therapeutic covivio in 268 patients with type 2 diabetes mellitus (T2DM). Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to covivio in addition to treatment as usual (TAU, n = 134), or to a control group, in which they will receive only TAU (n = 134).
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.
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Exclusion Criteria:
online intervention: covivio in addition to treatment as usual
Behavioral: covivio (additional to treatment as usual)
Other: treatment as usual
Other: 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.
Participants may continue with any treatment that they require (treatment as usual)
HbA1c
The primary objective of this study is to determine whether the online intervention covivio will reduce HbA1c values in the intervention group compared to the control group.
Time frame: 6 months
Depressive symptoms
assessed with the total score of the Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Diabetes Self-management
assessed with the total mean score of the Diabetes Self-management questionnaire (DSMQ)
Time frame: 6 months
Body Mass Index
calculated from measurement data of patient's height in meter and weight in kilogram
Time frame: 6 months
Health-Related Quality of Life
assessed with the total score of the Assessment of Quality of Life (AQoL-8D)
Time frame: 6 months
Proportion of patients achieving a reduction in HbA1c
A reduction of HbA1c values by at least 0.3% from baseline to T2 will be considered a significant clinical improvement in glycemic control
Time frame: 6 months
Waist circumference
measured at the midpoint between the lower rib and iliac crest in centimeters
Time frame: 6 months
systolic blood pressure
measured with a calibrated sphygmomanometer while the subject is sitting
Time frame: 6 months
This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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