Diabetes Mellitus Type 2ONSIDENCT03181737
Psychological Online-training to Optimize Adherence in Patients With Type-II Diabetes
A study testing Covivio/Relaxio in people with Diabetes Mellitus Type 2, run by Philipps University Marburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Covivio/Relaxio
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 3 Aug 2017to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Covivio/Relaxio
- Keywords
- diabetes mellitus typ 2, adherence, psychological online-intervention, randomized controlled study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covivio/RelaxioBehavioural
Informations already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes from baseline to 2, 5 and 8 months post-baseline.
Secondary outcomes (7)
Glycemic control
Change in participant's HbA1c level
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed at 2 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start3 Aug 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Why it stopped: low adherence rate; need to revise online interventions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Yvonne Nestoriuc, Gaia AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181737
- Sponsor's protocol ID
- 2016-42k-r
- Acronym
- ONSIDE
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2017
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Online-training to Optimize Adherence in Patients With Type-II Diabetes a Randomized Controlled Trial (ONSIDE-study)
- ClinicalTrials.gov ID
- NCT03181737
- Acronym / sponsor ID
- ONSIDE / 2016-42k-r
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- diabetes mellitus typ 2, adherence, psychological online-intervention, randomized controlled study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low adherence rate; need to revise online interventions
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Prof. Dr. Yvonne Nestoriuc, Gaia AG
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Covivio | Experimental | Behavioral: Covivio/RelaxioCovivio 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. |
| Relaxio | Active comparator | Behavioral: Covivio/RelaxioRelaxio 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covivio/RelaxioInformations already included in arm/group descriptions. | Behavioural | Covivio, Relaxio |
Primary outcome
Diabetes Self-Management Questionnaire (DSMQ-R)
Time frame: Changes from baseline to 2, 5 and 8 months post-baseline.
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).
7 secondary outcomes
Glycemic control
Time frame: Change from baseline in HbA1c level to 3 months (also assessed at 6 months post baseline)
GLTEQ (Godin- Leisure- Time Exercise Questionnaire)
Time frame: changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
PAID (Polonsky, Problem Areas in Diabetes Questionnaire)
Time frame: Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
GAD-7 (Generalized Anxiety Disorder Assessment)
Time frame: Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
PHQ-9 (Patient Health Questionnaire)
Time frame: Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
WHO-5 (WHO-Five Well-Being Index)
Time frame: Changes from baseline to 2 months (also assessed at 5 and 8 months post baseline)
Subjective usefulness of the program
Time frame: Assessed at 2 months post baseline
Results and safety
The study was stopped early (reason given: low adherence rate; need to revise online interventions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covivio/Relaxio in people with Diabetes Mellitus Type 2, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low adherence rate; need to revise online interventions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management Questionnaire (DSMQ-R) (time frame: Changes from baseline to 2, 5 and 8 months post-baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.