Type 2 DiabetesNCT02137720
Translating Telephonic Diabetes Self-management Support to Primary Care Practice
A study testing Telephonic Diabetes Self-Management Support and Educational Print Materials in people with Type 2 Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Telephonic Diabetes Self-Management Support and Educational Print Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 20 Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years of age and older
- Receiving treatment for diabetes at selected primary care practices throughout New York City
- Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization)
- Ability to speak and read English or Spanish (or someone in the household who will read to them)
- Access to a telephone
- Willing to give informed consent to participate and accept random assignment.
Who cannot join
- Stated intention to move out of the New York City area during the next year
- Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff
- Treatment provider deems that the patient is inappropriate for the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
New York City Department of Health and Mental Hygiene
New York, New York, 11101
About this study
Official title: Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial
The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.
- Conditions
- Type 2 Diabetes
- Being tested
- Telephonic Diabetes Self-Management Support, Educational Print Materials
- Keywords
- Diabetes, Treatment Adherence, Self-management, Emotional Distress, Diabetes-related Distress
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic Diabetes Self-Management SupportBehavioural
Educational Print MaterialsOther
| Study group | Role | What they receive |
|---|---|---|
| Telephonic Diabetes Self-Management Support | Experimental | This group receives all the Educational Print Materials received by the comparison condition plus telephone calls from a health educator to provide tailored diabetes self-management training and support. Participants with significant emotional distress at baseline also receive additional calls focused on distress management. Receives: Behavioral: Telephonic Diabetes Self-Management Support |
| Educational Print Materials | Active comparator | Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression. Receives: Other: Educational Print Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Obtained from electronic medical record.
Measured: Change from baseline at 12 months
Secondary outcomes (6)
Diabetes Self-Management
Measured by self-report questionnaire
Measured: Change from baseline at 12 months
Medication Adherence
Measured by self-report questionnaire
Measured: Change from baseline at 12 months
Diabetes-related distress
Measured by self-report questionnaire
Measured: Change from baseline at 12 months
Depressive symptoms
Measured by self-report questionnaire
Measured: Change from baseline at 12 months
Blood pressure
Obtained from electronic medical record.
Measured: Baseline and 12 months
Cholesterol
Obtained from electronic medical record.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJun 2014
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York City Department of Health and Mental Hygiene
- Responsible party
- Principal investigator, Jeffrey Gonzalez, Albert Einstein College of Medicine
- Investigators
- Jeffrey S Gonzalez, PhD, Principal investigator, Albert Einstein College of MedicineWinfred Y Wu, MD, MPH, Principal investigator, New York City Department of Health and Mental Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137720
- Sponsor's protocol ID
- 2012-422
- Other IDs
- 1R18DK098742-01A1
- Status last verified
- Jul 2020
- First submitted
- 8 May 2014
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez JS, Hoogendoorn CJ, Linnell J, Fishman S, Jonas V, Pham-Singer H, Schechter CB, Walker EA, Wu WY. Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support. Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3.
PubMed 33022367
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial
- ClinicalTrials.gov ID
- NCT02137720
- Acronym / sponsor ID
- 2012-422
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Treatment Adherence, Self-management, Emotional Distress, Diabetes-related Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York City Department of Health and Mental Hygiene
- Study start
- Jun 2014 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 14 May 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.
The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephonic Diabetes Self-Management Support | Experimental | Behavioral: Telephonic Diabetes Self-Management SupportThis group receives all the Educational Print Materials received by the comparison condition plus telephone calls from a health educator to provide tailored diabetes self-management training and support. Participants with significant emotional distress at baseline also receive additional calls focused on distress management. |
| Educational Print Materials | Active comparator | Other: Educational Print MaterialsParticipants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 years of age and older
- Receiving treatment for diabetes at selected primary care practices throughout New York City
- Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization)
- Ability to speak and read English or Spanish (or someone in the household who will read to them)
- Access to a telephone
Key exclusion criteria (3 listed)
- Stated intention to move out of the New York City area during the next year
- Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff
- Treatment provider deems that the patient is inappropriate for the trial
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 |
|---|---|---|
| Telephonic Diabetes Self-Management Support | Behavioural | Telephonic Diabetes Self-Management Support |
| Educational Print Materials | Other | Educational Print Materials |
Primary outcome
HbA1c
Time frame: Change from baseline at 12 months
Obtained from electronic medical record.
6 secondary outcomes
Diabetes Self-Management
Time frame: Change from baseline at 12 months
Medication Adherence
Time frame: Change from baseline at 12 months
Diabetes-related distress
Time frame: Change from baseline at 12 months
Depressive symptoms
Time frame: Change from baseline at 12 months
Blood pressure
Time frame: Baseline and 12 months
Cholesterol
Time frame: Baseline and 12 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 27 Jul 2020.
- Derived from this study: PubMed 33022367Gonzalez JS, Hoogendoorn CJ, Linnell J, Fishman S, Jonas V, Pham-Singer H, Schechter CB, Walker EA, Wu WY. Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support. Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3.
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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.
Jeffrey S Gonzalez, PhD principal investigator
Albert Einstein College of Medicine
Winfred Y Wu, MD, MPH principal investigator
New York City Department of Health and Mental Hygiene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephonic Diabetes Self-Management Support and Educational Print Materials in people with Type 2 Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 27 Jul 2020. 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 United States. 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 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 (time frame: Change from baseline at 12 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 NCT02137720, which also lists 1 linked publication.
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 27 Jul 2020.