Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM
NCT ID: NCT06529965
Last Updated: 2024-11-08
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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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-10-09
2026-04-09
Brief Summary
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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 = 125), or to a control group, in which they will receive only TAU (n = 125).
Co-primary endpoints of this trial will be the between-groups difference in the PAID-20 total score in the intervention and control group at six months, adjusted for the PAID-20 baseline score as well as the glucose management indicator (estimated HbA1c) assessed using continuous glucose monitoring devices (for a period of 7 days) at six months, adjusted for the baseline score.
Secondary endpoints will be diabetes self-management skills, body mass index (BMI), and quality of life.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention/Treatment
Experimental: covivio + TAU
Participants allocated to the intervention group will receive access to covivio in addition to treatment as usual (TAU).
covivio is a digital health application designed for individuals with type 2 diabetes mellitus who suffer from elevated levels of diabetes-specific emotional distress, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by covivio are disease literacy, physical activity and exercise, nutrition, stress management, sleep management, mood problems, and social resources.
The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.
covivio
Participants will receive access to the digital health intervention covivio in addition to TAU.
Control
No Intervention: TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
No interventions assigned to this group
Interventions
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covivio
Participants will receive access to the digital health intervention covivio in addition to TAU.
Eligibility Criteria
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Inclusion Criteria
* age ≥ 18 years
* diagnosis of T2DM secured via 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
* elevated levels of diabetes-specific emotional distress: cut-off ≥ 33 on the PAID-20
* access to CGM-compatible smartphone
* consent to participate
* sufficient knowledge of the German language
Exclusion Criteria
* change in medication (type, frequency of use or dosage) within 4 weeks before the baseline visit or planned within the subsequent 6 months
* recent or planned bariatric operation within 4 weeks before the baseline visit or within the subsequent 6 months
* change in psychotherapeutic treatment within 4 weeks before the baseline visit or planned within the subsequent 6 months
* current use of continuous glucose monitoring (CGM) as part of one's diabetes treatment
* experiencing problems with the CGM sensor or insufficient CGM data quality at baseline (T0) (i.e., wearing the CGM sensor on less than 6 of 7 days, providing less than a minimum of 96 hours of glucose values, providing less than 24 hours overnight CGM data)
18 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Philipps University Marburg
OTHER
Gaia AG
INDUSTRY
Responsible Party
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Principal Investigators
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Kamila Jauch-Chara, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Zentrum für Integrative Psychiatrie, Universitätsklinikum Schleswig-Holstein
Locations
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GAIA AG
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Gitta A Jacob, PhD
Role: primary
Katharina M Rischer, PhD
Role: backup
Other Identifiers
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covivio RCT 2024
Identifier Type: -
Identifier Source: org_study_id
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