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

Psychological Online-training to Optimize Adherence in Patients With Type-II Diabetes a Randomized Controlled Trial (ONSIDE-study)

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Behavioral: Covivio/Relaxio

Detailed Description

The treatment of diabetes type 2 is a major challenge for the health care system. According to the International Diabetes Federation (IDF), around 382 million people between the ages of 20 and 79 are currently affected worldwide. The presence of diabetes is associated with personal suffering, impaired quality of life and a deficient treatment leads to complications like retinal ablation, neuropathy, nephropathy and the diabetic-foot syndrome. An appropriate treatment is dedicated to the purpose of adjusting the blood glucose, is very complex and involves many areas of life. Internet-administrated psychological interventions are easily accessible and preliminary evidence suggests that online programs promote lifestyle changes, i.e. nutrition and exercises, of people with diabetes mellitus type 2. However, no trial has yet examined weather a CBT-based internet intervention designed to meet the needs of PwDM can achieve sustained improve adherence behavior like nutrition, physical activity and medication intake, when offered as adjunct to treatment as usual.

The internet-based intervention evaluated in this trial was designed with the aim of enhancing adherence to PwDM over a period of 60 days. The intervention focuses issues in disease self-management including lifestyle habits (e.g. nutrition, exercise) and medication adherence. The program comprised psychotherapeutic techniques gleaned primarily from CBT to promote motivation for health behavior, conveying goal setting, mediating knowledge about diabetes (basics, symptoms & complications, diagnosis, therapy) , and increasing activation to reduce depressive symptoms and increasing mindfulness skills. The delivery and training of content is continuously individualized to match users' preferences and needs, based on responses within the program. The intervention is delivered via the Internet and protected by individually assigned passwords.

This randomized controlled trial will include 300 participants with diabetes mellitus type 2. Participants will be recruited from various settings, including diabetes outpatient treatment centers and internet forums/groups. Methods such as newspaper articles, flyers, posters, and media articles will be used to inform potential participants about the study (all material will be in German). Participants will be screened for inclusion and exclusion criteria via telephone, and randomly assigned to either (1) a treatment group that may use care as usual (CAU) and in addition immediately receives two-month access to the novel, internet -administrated intervention (Covivio), (2) an active control group that may also use CAU and in addition immediate receives two-month access to a psychological online-relaxation-training (Relaxio), or (3) a wait list control group, in which they receive CAU. Measurements are collected online at pre-treatment (T0), post-treatment (T1), and three (T2) and six months (T3) follow-up. After the last follow-up (T3), all participants gain access to the online-program which they had not yet been able to use.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35032
      • Department of Psychology, Philipps University Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• newly prescribed diabetes medication or change in diabetes medication dosage in month prior to study inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Covivio; 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; Informations already included in arm/group descriptions.
ACTIVE_COMPARATOR: Relaxio; 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; Informations already included in arm/group descriptions.
NO_INTERVENTION: Care-as-Usual (CAU) / wait list; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Change in participant's HbA1c level	Change from baseline in HbA1c level to 3 months (also assessed at 6 months post baseline)
GLTEQ (Godin- Leisure- Time Exercise Questionnaire)	Self-report measure of leisure-time exercise habits	changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
PAID (Polonsky, Problem Areas in Diabetes Questionnaire)	Self-report measure of diabetes specific strains	Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
GAD-7 (Generalized Anxiety Disorder Assessment)	Self-report anxiety symptom severity measure	Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
PHQ-9 (Patient Health Questionnaire)	Self-report measure of depressive symptoms	Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
WHO-5 (WHO-Five Well-Being Index)	Self-report measure of general well-being	Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
Subjective usefulness of the program	Individually designed self-report items	Assessed at 2 months post baseline

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Collaborators: Gaia AG; Prof. Dr. Yvonne Nestoriuc

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2017
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (ACTUAL): June 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: diabetes mellitus typ 2, adherence, psychological online-intervention, randomized controlled study
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2016-42k-r

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No