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

Diabetes Mellitus Type 2 Clinical Trial

— ONSIDE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03181737
• Other study ID #: 2016-42k-r
• Status: Terminated
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Covivio/Relaxio
Informations already included in arm/group descriptions.

Locations

Country	Name	City	State
Germany	Department of Psychology, Philipps University Marburg	Marburg	Hessen

Sponsors (3)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Gaia AG, Prof. Dr. Yvonne Nestoriuc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glycemic control	Change in participant's HbA1c level	Change from baseline in HbA1c level to 3 months (also assessed at 6 months post baseline)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Subjective usefulness of the program	Individually designed self-report items	Assessed at 2 months post baseline