Type 2 DiabetesCHANGE-DNCT02179385
Empowerment and Support for the Diabetic Patient
A study testing Health Coaching in people with Type 2 Diabetes, run by Clalit Health Services.
Trial summary
CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2016
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- At least one oral anti diabetic drug
- HbA1c above 7.5% ot above 0.5% of personal target
- Preparedness for change
- Fluent Hebrew or Arabic
Who cannot join
- Type 1 diabetes
- Pregnancy or lactation
- Incompetency to sign consent
- Participation in another clinical trial
- Unstable psychotic disease
- Complex health condition
About this study
Official title: Coaching for Health to Achieve New Goals in Empowerment for Diabetes
CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.
Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.
Read the detailed description
Research Group 300 type 2 diabetics: 150 from Jewish sector and 150 from Arab sector will be recruited from 7-10 clinics in each district: North District and Haifa District A personal coaching intervention will be tailored from the offered tools: Face to face, group, telephone Participants will be monitored for clinical and self treatments outcomes Comparison Group 300 patients with similar characteristics to the research group will receive Clalit's standard of care Participants will be monitored for clinical and self treatments outcomes like the research group
- Conditions
- Type 2 Diabetes
- Being tested
- Health Coaching
- Keywords
- Type 2 diabetes, Type II diabetes
- 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.
Health CoachingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Health coaching | Experimental | Patients receive health coaching via the phone, face to face or group support, according to patients' choice Receives: Behavioral: Health Coaching |
| Standard of Care | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical composite
Change from baseline in a composite endpoint of HbA1c, BMI, Blood Pressure, Lipids at 6, 12 and 18 months from randomization
Measured: 0, 6, 12, 18 months from randomization
Secondary outcomes (2)
Change in Self Treatment Score
Change from baseline in Self treatment diabetes questionnaire score at 6, 12 and 18 months from randomization
Measured: 0, 6, 12, 18 months from randomization
Change in Self Efficacy Score
Change from baseline in Self Efficacy questionnaire score at 6, 12 and 18 months from randomization
Measured: 0, 6, 12, 18 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Margalit (Margita) Goldfracht, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179385
- Sponsor's protocol ID
- 0130-13-COM
- Acronym
- CHANGE-D
- Status last verified
- Aug 2015
- First submitted
- 25 Jun 2014
- Last updated
- 6 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching for Health to Achieve New Goals in Empowerment for Diabetes
- ClinicalTrials.gov ID
- NCT02179385
- Acronym / sponsor ID
- CHANGE-D / 0130-13-COM
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Type II diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 1 Jul 2014 (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.
CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.
Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.
Detailed description
Research Group 300 type 2 diabetics: 150 from Jewish sector and 150 from Arab sector will be recruited from 7-10 clinics in each district: North District and Haifa District A personal coaching intervention will be tailored from the offered tools: Face to face, group, telephone Participants will be monitored for clinical and self treatments outcomes Comparison Group 300 patients with similar characteristics to the research group will receive Clalit's standard of care Participants will be monitored for clinical and self treatments outcomes like the research group
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health coaching | Experimental | Behavioral: Health CoachingPatients receive health coaching via the phone, face to face or group support, according to patients' choice |
| Standard of Care | Placebo comparator | – |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- At least one oral anti diabetic drug
- HbA1c above 7.5% ot above 0.5% of personal target
- Preparedness for change
- Fluent Hebrew or Arabic
Key exclusion criteria (6 listed)
- Type 1 diabetes
- Pregnancy or lactation
- Incompetency to sign consent
- Participation in another clinical trial
- Unstable psychotic disease
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 |
|---|---|---|
| Health Coaching | Behavioural | Health coaching |
Primary outcome
Clinical composite
Time frame: 0, 6, 12, 18 months from randomization
Change from baseline in a composite endpoint of HbA1c, BMI, Blood Pressure, Lipids at 6, 12 and 18 months from randomization
2 secondary outcomes
Change in Self Treatment Score
Time frame: 0, 6, 12, 18 months from randomization
Change in Self Efficacy Score
Time frame: 0, 6, 12, 18 months from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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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 Health Coaching in people with Type 2 Diabetes, run by Clalit Health Services.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Aug 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. Some participants in this study may receive a placebo. 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?
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?
Clinical composite (time frame: 0, 6, 12, 18 months from randomization). 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 6 Aug 2015.