Diabetes Mellitus, Type 2NCT03168633
Lifestyle Advises Sent Via Email in Attempt of Improving A1C in DM2 Patients
A study testing web-based DM2 information pages in people with Diabetes Mellitus, Type 2, run by Rambam Health Care Campus.
Trial summary
Diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. Previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes. 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?
- web-based DM2 information pages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 30 Jan 2017
- 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
- Previous diabetes specialist follow
- Age over 18.
- Diagnosis of diabetes type 2.
- HbA1c over 7%
- Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.
- Able to read Hebrew
- Uses Email account that is actively read at least twice weekly.
Who cannot join
- Patients who did not the inclusion criteria
About this study
Official title: Effects of Reading Information Sent Via Email and Glycemic Control and Compliance to Recommendations Among Patients With Type 2 Diabetes Mellitus -Prospective Research
Diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. Previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes.
This trial focuses on delivering these reminders, via email, in attempt to improve the patients glycemic control (measured in Hemoglobin A1C)
Read the detailed description
The study initially included 50 patients (men and women, over 18 years of age) who were prior diagnosed with DM2 and unbalanced in their glycemic values (HbA1c above 7%). The patient were sent via email , once every other week, a link to web-based pages which provides information on changing DM2 related such as general DM2 information, the importance of keeping a well-balanced diet, benefits of exercising regularly, drug related information and more.
Furthermore, the patients were sent a questionnaire every other week which they were asked to actively reply to.
Each participating patient was monitored for 6 months, during this time he/she was sent 12 web-based information pages.
During the course of the study, information regarding the patients' glycemic control (in the form of HgA1c levels) was collected.
Additional variables (age, sex, BMI, time passed since diagnosed with DM2) were collected and used for statistical comparison.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- web-based DM2 information pages
- Keywords
- : Type 2 Diabetes Mellitus, Web-based intervention, medication adherence, lifestyle changes
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based DM2 information pagesBehavioural
Each email will include information on one of the following topics:
- The importance of physical activity
- Correct nutrition
- The importance of adhering to medication regimens.
Emails will be either positive (e.g., the importance of good nutrition, and what constitutes good nutrition) or negative (e.g., the risks of not adhering to medications).
The information will be provided by different approaches: medical research results, practical tips, patient testimonies.…
| Study group | Role | What they receive |
|---|---|---|
| patients receiving emails | Experimental | Diagnosed DM2 patients who meet inclusion criteria. the patients will receive emails containing information about DM2 as a method of reminding patients of the importance of adjusting post diagnosis life-style changes.
web-based DM2 information pages Receives: Behavioral: web-based DM2 information pages |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C values of patients after 6 months
HbA1C values
Measured: 6 months follow up
Secondary outcomes (1)
percentage of messages opened and read
reading of each message will be recorded
Measured: 10-12 messages in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startJul 2015
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irit Hochberg, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168633
- Sponsor's protocol ID
- 0456-14-RMB CTIL
- Status last verified
- May 2017
- First submitted
- 1 Feb 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reading Information Sent Via Email and Glycemic Control and Compliance to Recommendations Among Patients With Type 2 Diabetes Mellitus -Prospective Research
- ClinicalTrials.gov ID
- NCT03168633
- Acronym / sponsor ID
- 0456-14-RMB CTIL
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- : Type 2 Diabetes Mellitus, Web-based intervention, medication adherence, lifestyle changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 30 May 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.
Diabetic patients need to manage their glucose level, physical activity and food intake to successfully cope with their disease. Previous work has shown that reminders of the disease, be they informational or about ones' condition, can improve management of disease in diabetes.
This trial focuses on delivering these reminders, via email, in attempt to improve the patients glycemic control (measured in Hemoglobin A1C)
Detailed description
The study initially included 50 patients (men and women, over 18 years of age) who were prior diagnosed with DM2 and unbalanced in their glycemic values (HbA1c above 7%). The patient were sent via email , once every other week, a link to web-based pages which provides information on changing DM2 related such as general DM2 information, the importance of keeping a well-balanced diet, benefits of exercising regularly, drug related information and more.
Furthermore, the patients were sent a questionnaire every other week which they were asked to actively reply to.
Each participating patient was monitored for 6 months, during this time he/she was sent 12 web-based information pages.
During the course of the study, information regarding the patients' glycemic control (in the form of HgA1c levels) was collected.
Additional variables (age, sex, BMI, time passed since diagnosed with DM2) were collected and used for statistical comparison.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients receiving emails | Experimental | Behavioral: web-based DM2 information pagesDiagnosed DM2 patients who meet inclusion criteria. the patients will receive emails containing information about DM2 as a method of reminding patients of the importance of adjusting post diagnosis life-style changes. web-based DM2 information pages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Previous diabetes specialist follow
- Age over 18.
- Diagnosis of diabetes type 2.
- HbA1c over 7%
- Self-admitted less than optimal adherence to physical activity, diet or medications or computer-recorded less than 80% adherence to medication purchase.
Key exclusion criteria (1 listed)
- Patients who did not the inclusion criteria
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 |
|---|---|---|
| web-based DM2 information pagesEach email will include information on one of the following topics: 1. The importance of physical activity 2. Correct nutrition 3. The importance of adhering to medication regimens. Emails will be either positive (e.g., the importance of good nutrition, and what constitutes good nutrition) or negative (e.g., the risks of not adhering to medications). The information will be provided by different approaches: medical research results, practical tips, patient testimonies.… | Behavioural | patients receiving emails |
Primary outcome
HbA1C values of patients after 6 months
Time frame: 6 months follow up
HbA1C values
1 secondary outcome
percentage of messages opened and read
Time frame: 10-12 messages in 6 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 30 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Irit Hochberg, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing web-based DM2 information pages in people with Diabetes Mellitus, Type 2, run by Rambam Health Care Campus.
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 1 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 30 May 2017. 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?
HbA1C values of patients after 6 months (time frame: 6 months follow up). 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 30 May 2017.