Psychological Online-training to Optimize Adherence in Patients With Type-II Diabetes

NCT03181737 | Terminated

• 1 other identifier: 2016-42k-r
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The trial aim of the study is to evaluate the effectiveness of a novel psychological internet intervention (Covivio), which was designed to improve adherence in Persons with Diabetes Mellitus type 2 (PwDM), using cognitive-behavioral therapy (CBT) techniques. Therefore, 300 PwDM will be recruited and randomized to three groups: (1) a treatment group that immediately receives two-month access to Covivio and may also use care-as-usual (CAU), (2) an active control group that also immediately receives a two-month access to Relaxio, an internet program with the focus of stress relaxation ,and may also additionally use CAU or (3) a control group, in which they may engage with any diabetes treatment (i.e. CAU/ wait list control group). The active control group (2) and the wait control group (3) receive access to Covivio after a delay of six months. The primary outcome measure is the Diabetes Self-Management Questionnaire-Revised (DSMQ-R), collected at baseline, two (post-treatment), and additionally three and six months follow-up.

Conditions

Diabetes Mellitus Type 2

Keywords

diabetes mellitus typ 2, adherence, psychological online-intervention, randomized controlled study

Outcome Measures

Primary Outcomes (1)

• Diabetes Self-Management Questionnaire (DSMQ-R)

  Self-report of diabetes self-management , to measure adherence to diabetes treatment. Diabetes self-management behavior with a focus on behavioral patterns which contribute to a stable blood glucose level (nutrition, medication adherence, blood glucose self-monitoring, exercise, regular medical examinations).

  Changes from baseline to 2, 5 and 8 months post-baseline.

Secondary Outcomes (7)

• Glycemic control

  Change from baseline in HbA1c level to 3 months (also assessed at 6 months post baseline)

• GLTEQ (Godin- Leisure- Time Exercise Questionnaire)

  changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)

• PAID (Polonsky, Problem Areas in Diabetes Questionnaire)

  Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)

• GAD-7 (Generalized Anxiety Disorder Assessment)

  Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)

• PHQ-9 (Patient Health Questionnaire)

  Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)

Study Arms (3)

Covivio

EXPERIMENTAL

Covivio is an internet intervention for people with diabetes mellitus type 2. Content is continuously adapted to patients´ concerns and needs. Techniques to promote the disease self-management (i.e. nutrition, exercise), the motivation for health behavior (i.e. discussing pros and cons) conveying goal setting, mediating knowledge about diabetes (i.e. basics, symptoms \& complications, diagnosis, therapy) , and reducing depressive symptoms (i.e. increasing activation, mindfulness exercises) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Patients are also prompted complete brief adherence self-monitoring questionnaires (adherence index) regularly. Optional text messages with motivational content accompany the program daily. The program can be accessed for 56 days after registration.

Behavioral: Covivio/Relaxio

Relaxio

ACTIVE COMPARATOR

Relaxio is a psychological online-relaxation-training. The purpose of the program is to improve the self-management of diabetes by relaxation and stress reduction. The program consist of three types of exercises (1) imagination (i.e. sunset, mountain lake), (2) breathing techniques (i.e. balancing, calm breathing), and (3) body exercises (i.e. relaxing body journey, progressive muscle relaxation (PMR)). The exercises are supported by audio files (optionally also for reading). Optional weekly text messages with motivational content accompany the program. The program can be accessed for 56 days after registration.

Behavioral: Covivio/Relaxio

Care-as-Usual (CAU) / wait list

NO INTERVENTION

In the CAU/wait list control group, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Covivio six months post-baseline (i.e., wait list with respect to Covivio access).

Interventions

Covivio/Relaxio BEHAVIORAL

Informations already included in arm/group descriptions.

Covivio; Relaxio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• Diagnosis of type 2 diabetes mellitus (T2DM) and HbA1c \> 6,5%;
• currently deficient self-management behavior, as operationalized by a score of less then 7,5 on the DSMQ-R
• Regular control (every 3 months) of the HbA1c by physicians during the study period
• ability to speak and read German
• access to the internet and personal possession of an appropriate device on which the internet-based intervention can be used regularly (e.g., smartphone, computer, laptop)
• expressed motivation to participate in the trial and use an internet-based intervention to acquire skills and knowledge that may aid in the treatment of diabetes mellitus

You may not qualify if:

• other known major mental disorder, such as bipolar disorder, schizophrenia or another psychotic disorder, or borderline personality disorder (based on the MINI interview) or acute and serve physical disease
• acute suicidality (that is, intention or plan to commit suicide, as assessed with the respective module of the MINI interview)

Sponsors & Collaborators

• Philipps University Marburg: lead
• Prof. Dr. Yvonne Nestoriuc: collaborator
• Gaia AG: collaborator

Study Sites (1)

Department of Psychology, Philipps University Marburg

Marburg, Hesse, 35032, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: August 3, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)