Type 2 Diabetes MellitusNCT01612520
Telecoaching of People With Type 2 Diabetes in Primary Care
A study testing telecoaching in people with Type 2 Diabetes Mellitus and Telenursing, run by KU Leuven.
Trial summary
The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Telenursing
- What is being tested?
- telecoaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jan 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with type 2 diabetes between 18 and 75 years old on the day of the selection
Who cannot join
- Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)
- Residents of long term care facilities
- Pregnancy
- Incapable of telephone communication in Dutch
About this study
The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.
- Conditions
- Type 2 Diabetes Mellitus, Telenursing
- Being tested
- telecoaching
- Keywords
- type 2 Diabetes Mellitus, telenursing, RCT, economic analysis
- 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.
telecoachingBehavioural
The COACH program trains patients to 'drive' the process of achieving and maintaining the target levels for their risk factors while working in association with their GP. The telephone coaching is aimed at improving self-efficacy by adhering to the prescribed therapy and making relevant behavior changes.
The coaching model is a continuous five-stage coaching cycle: Stage 1. Finding out what the patient knows; Stage 2. Telling the patient what they should know; Stage 3. Assertiveness training; Stage 4. Setting an action plan; Stage 5. Reassessment at the next coaching session (monitoring).
The coach monitors and registers: the biomedical risk factors, the lifestyle/behavioral risk factors and use of the recommended medications. Coaching is focused on eliminating the knowledge gap and motivating the patient to apply the appropriate lifestyle and medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| telecoaching | Active comparator | Not described Receives: Behavioral: telecoaching |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the absolute change in HbA1c
Measured: baseline; 6 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Odnoletkova, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612520
- Sponsor's protocol ID
- S53665
- Status last verified
- Feb 2015
- First submitted
- 4 Jun 2012
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Odnoletkova I, Buysse H, Nobels F, Goderis G, Aertgeerts B, Annemans L, Ramaekers D. Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial. BMC Med Inform Decis Mak. 2016 Nov 9;16(1):142. doi: 10.1186/s12911-016-0383-3.
PubMed 27825340Odnoletkova I, Ramaekers D, Nobels F, Goderis G, Aertgeerts B, Annemans L. Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis. PLoS One. 2016 Oct 11;11(10):e0163997. doi: 10.1371/journal.pone.0163997. eCollection 2016.
PubMed 27727281Odnoletkova I, Goderis G, Nobels F, Aertgeerts B, Annemans L, Ramaekers D. Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial. BMC Fam Pract. 2014 Feb 4;15:24. doi: 10.1186/1471-2296-15-24.
PubMed 24495633
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telecoaching of People With Type 2 Diabetes in Primary Care
- ClinicalTrials.gov ID
- NCT01612520
- Acronym / sponsor ID
- S53665
- Conditions
- Type 2 Diabetes Mellitus, Telenursing
- Keywords
- type 2 Diabetes Mellitus, telenursing, RCT, economic analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Jun 2012 (estimated)
- 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 objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telecoaching | Active comparator | Behavioral: telecoaching |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with type 2 diabetes between 18 and 75 years old on the day of the selection
Key exclusion criteria (4 listed)
- Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer)
- Residents of long term care facilities
- Pregnancy
- Incapable of telephone communication in Dutch
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 |
|---|---|---|
| telecoachingThe COACH program trains patients to 'drive' the process of achieving and maintaining the target levels for their risk factors while working in association with their GP. The telephone coaching is aimed at improving self-efficacy by adhering to the prescribed therapy and making relevant behavior changes. The coaching model is a continuous five-stage coaching cycle: Stage 1. Finding out what the patient knows; Stage 2. Telling the patient what they should know; Stage 3. Assertiveness training; Stage 4. Setting an action plan; Stage 5. Reassessment at the next coaching session (monitoring). The coach monitors and registers: the biomedical risk factors, the lifestyle/behavioral risk factors and use of the recommended medications. Coaching is focused on eliminating the knowledge gap and motivating the patient to apply the appropriate lifestyle and medical therapy. | Behavioural | telecoaching |
Primary outcome
the absolute change in HbA1c
Time frame: baseline; 6 months and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Derived from this study: PubMed 27825340Odnoletkova I, Buysse H, Nobels F, Goderis G, Aertgeerts B, Annemans L, Ramaekers D. Patient and provider acceptance of telecoaching in type 2 diabetes: a mixed-method study embedded in a randomised clinical trial. BMC Med Inform Decis Mak. 2016 Nov 9;16(1):142. doi: 10.1186/s12911-016-0383-3.
- Derived from this study: PubMed 27727281Odnoletkova I, Ramaekers D, Nobels F, Goderis G, Aertgeerts B, Annemans L. Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis. PLoS One. 2016 Oct 11;11(10):e0163997. doi: 10.1371/journal.pone.0163997. eCollection 2016.
- Derived from this study: PubMed 24495633Odnoletkova I, Goderis G, Nobels F, Aertgeerts B, Annemans L, Ramaekers D. Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial. BMC Fam Pract. 2014 Feb 4;15:24. doi: 10.1186/1471-2296-15-24.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing telecoaching in people with Type 2 Diabetes Mellitus and Telenursing, run by KU Leuven.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the absolute change in HbA1c (time frame: baseline; 6 months and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612520, which also lists 3 linked publications.
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 3 Feb 2015.