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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluating the Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus (Covivio): Randomized Controlled Trial

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: covivio (additional to treatment as usual)
* Other: treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of T2DM (submission of a medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses of T2DM: E11.20, E11.30, E11.40, E11.50, E11.60, E11.72, E11.74, E11.80, E11.90) HbA1c value ≥ 7.0% (53 mmol/mol) BMI ≥ 23 kg/m2 Consent to participate Sufficient knowledge of the German language Exclusion Criteria: diagnosis of type 1 diabetes mellitus (T1DM) change in medication, frequency of use or dosage (planned within 4 weeks before T0 or during the study period)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: online intervention in addition to treatment-as-usual<br>online intervention: covivio in addition to treatment as usual | Behavioral: covivio (additional to treatment as usual)<br>* 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.<br>|
| Other: treatment-as-usual<br>Other: treatment as usual | Other: treatment as usual<br>* Participants may continue with any treatment that they require (treatment as usual)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | assessed with the total score of the Patient Health Questionnaire (PHQ-9) | 6 months | 
| Diabetes Self-management | assessed with the total mean score of the Diabetes Self-management questionnaire (DSMQ) | 6 months | 
| Body Mass Index | calculated from measurement data of patient's height in meter and weight in kilogram | 6 months | 
| Health-Related Quality of Life | assessed with the total score of the Assessment of Quality of Life (AQoL-8D) | 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 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, covivio, diabetes self-management, digital health application