Type 2 DiabetesNCT02530840
Improving Adherence and Commitment to Treatment in Diabetic Patients
A study testing medical team, peers group and SMS notification in people with Type 2 Diabetes, run by Clalit Health Services at 1 site in Israel.
Trial summary
In the IMPACT project, the investigators want to improve adherence and commitment to treatment. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- medical team, peers group and SMS notification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Mar 2018
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- age 30-70
- Oral medication or insulin
- According to the HbA1c test result, 0.5% above the target for the patient's personal balance and below the 10%, the most recent, but in any event not more than six months prior to the study patient recruitment
- BMI<35
- Patients speak and read Hebrew
- owners of a mobile phone that can receive text messages (SMS messages/ notifications) and have the ability to use the application (relevant for the SMS notification arm)
Who cannot join
- Active malignant disease
- creatinine levels above 2
- Getting medicines that elevate sugar levels as steroids, chemotherapy
- Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event
- Patients who are planning major surgery
- Patients who are planning a residential zone change
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- Patients with acute complications of diabetes under active treatment (such as limb amputation)
- Patients diagnosed with unbalanced mental disorders
- patients who can not sign the form on their own "informed consent"
- patients suffering from dementia
- Patients who are not mobile (dependent on the therapist)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Clalit Health Institute
Tel Aviv
margalit Goldfracht, prof, +972-506263214, goldfrac@actcom.co.il
About this study
Official title: Impact:Improving Adherence and Commitment to Treatment
In the IMPACT project, the investigators want to improve adherence and commitment to treatment.
Read the detailed description
In this study the investigators use 3 interventions in diabetic patients and one control, to find what is the best intervention to improve adherence to healthy life style and medication therapy. the 3 intervention as followed: 1) meetings and follow-up by the medical team; 2) meetings and follow-up by trained peers; 3) system for sending SMS, operate according to algorithm.
- Conditions
- Type 2 Diabetes
- Being tested
- medical team, peers group, SMS notification
- Keywords
- imbalanced diabetic patients, HbA1c, peers
- 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.
medical teamBehavioural
Lowering HbA1c by behavioral changes in meetings with the medical team.
peers groupBehavioural
Lowering HbA1c by behavioral changes in meetings with the peers group.
SMS notificationBehavioural
Lowering HbA1c by behavioral changes in meetings with the SMS notification
| Study group | Role | What they receive |
|---|---|---|
| medical team | Experimental | personal meetings and follow-up of un-balanced diabetic patients by trained medical team (nurse and doctor), which designed to promote adherence to healthy life style and medical therapy. Receives: Behavioral: medical team |
| peers group | Experimental | group meetings and follow-up of un-balanced diabetic patients by trained peers (peers: balanced diabetic patients),which designed to promote adherence to healthy life style and medical therapy. Receives: Behavioral: peers group |
| SMS notifications | Experimental | un-balanced diabetic patients receiving daily SMS with content,which designed to promote adherence to healthy life style and medical therapy. Receives: Behavioral: SMS notification |
| control | No intervention | un-balanced diabetic patients will get the basic and regular treatment for diabetic patients according to Clalit Health Services. In addition, the patients will have the same check-ups like all the patients in the experimental arms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Control as Expressed by the Change in HbA1c %
Participants will undergo HbA1c periodical lab test, the data needed for the trial will be extracted from electronic medical record
Measured: 0, 6, 12 & 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startJul 2014
- Primary completionFeb 2018 (estimated)
- Study completionMar 2018 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margalit Goldfracht, prof., Principal investigator, Director of the Department of promoting quality of family medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530840
- Sponsor's protocol ID
- 0025-14-COM
- Status last verified
- Jul 2016
- First submitted
- 16 Aug 2015
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact:Improving Adherence and Commitment to Treatment
- ClinicalTrials.gov ID
- NCT02530840
- Acronym / sponsor ID
- 0025-14-COM
- Conditions
- Type 2 Diabetes
- Keywords
- imbalanced diabetic patients, HbA1c, peers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 21 Aug 2015 (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.
In the IMPACT project, the investigators want to improve adherence and commitment to treatment.
Detailed description
In this study the investigators use 3 interventions in diabetic patients and one control, to find what is the best intervention to improve adherence to healthy life style and medication therapy. the 3 intervention as followed: 1) meetings and follow-up by the medical team; 2) meetings and follow-up by trained peers; 3) system for sending SMS, operate according to algorithm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| medical team | Experimental | Behavioral: medical teampersonal meetings and follow-up of un-balanced diabetic patients by trained medical team (nurse and doctor), which designed to promote adherence to healthy life style and medical therapy. |
| peers group | Experimental | Behavioral: peers groupgroup meetings and follow-up of un-balanced diabetic patients by trained peers (peers: balanced diabetic patients),which designed to promote adherence to healthy life style and medical therapy. |
| SMS notifications | Experimental | Behavioral: SMS notificationun-balanced diabetic patients receiving daily SMS with content,which designed to promote adherence to healthy life style and medical therapy. |
| control | No intervention | –un-balanced diabetic patients will get the basic and regular treatment for diabetic patients according to Clalit Health Services. In addition, the patients will have the same check-ups like all the patients in the experimental arms. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- type 2 diabetes
- age 30-70
- Oral medication or insulin
- According to the HbA1c test result, 0.5% above the target for the patient's personal balance and below the 10%, the most recent, but in any event not more than six months prior to the study patient recruitment
- BMI<35
Key exclusion criteria (11 listed)
- Active malignant disease
- creatinine levels above 2
- Getting medicines that elevate sugar levels as steroids, chemotherapy
- Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event
- Patients who are planning major surgery
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 |
|---|---|---|
| medical teamLowering HbA1c by behavioral changes in meetings with the medical team. | Behavioural | medical team |
| peers groupLowering HbA1c by behavioral changes in meetings with the peers group. | Behavioural | peers group |
| SMS notificationLowering HbA1c by behavioral changes in meetings with the SMS notification | Behavioural | SMS notifications |
Primary outcome
Diabetes Control as Expressed by the Change in HbA1c %
Time frame: 0, 6, 12 & 18 months
Participants will undergo HbA1c periodical lab test, the data needed for the trial will be extracted from electronic medical record
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Margalit Goldfracht, prof. principal investigator
Director of the Department of promoting quality of family medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical team, peers group and SMS notification in people with Type 2 Diabetes, run by Clalit Health Services at 1 site in Israel.
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 11 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 1 Feb 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margalit Goldfracht, prof. (+972-50-6263-214, MargalitGo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Control as Expressed by the Change in HbA1c % (time frame: 0, 6, 12 & 18 months). 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 1 Feb 2018.