Diabetes Mellitus, Type 2NCT00179374
Improving Diabetes Outcomes With Activity, Nutrition and Medication
A study testing Tailored telephone intervention of education and Print educational intervention in people with Diabetes Mellitus, Type 2, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This study has the following specific aims: 1. A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention. 2. A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Tailored telephone intervention of education and Print educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jul 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Taking oral diabetes medication
- At least 40 years old
- In a union-sponsored health plan with full medication coverage for at least a year
- Able to understand English or Spanish
- Informed consent
Who cannot join
- Currently in a diabetes education program
- Will lose health care eligibility within a year
- Unable to receive phone calls or mail
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Improving Diabetes Medication Adherence and Outcomes
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care.
Read the detailed description
Metabolic control of type 2 diabetes and prevention of its complications are related to management of blood glucose and other factors. Medication and lifestyle modifications are integral to most self-management plans; however, adherence remains a great challenge. Many patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for complications. This study is to evaluate the effectiveness and costs of a tailored, telephone intervention to promote adherence in middle-aged and older adults with type-2 diabetes who are members of a union/employer-sponsored health benefit plan. The target population includes English- and Spanish-speaking individuals from the health plan database.
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care. The study design is a randomized, controlled intervention trial with masking; the individual is the unit of sampling, assignment and analysis. After eligibility is assessed and consent is obtained by telephone, patients will be randomized to either the telephone intervention or standard are. Study outcomes will be medication adherence as measured from pharmacy records and metabolic control (HbA1c). A total of 556 patients with type 2 diabetes wil be randomized, which will provide 80% power to detect a statistically significant difference in HbA1c of at least 0.3%, and over 95% power to detect a difference in filled prescriptions. Telephone surveys will provide data on self-care behaviors including diet and exercise, risk perceptions, and depressive symptoms. Cost data will be collected using standardized methods. Study results will inform implementation of practical, nurse-managed interventions to improve medication adherence and metabolic control in diverse, middle-aged and older, type 2 diabetes patients, while linking changes in medication adherence to lifestyle modification for diet and physical activity.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Tailored telephone intervention of education, Print educational intervention
- Keywords
- Medication adherence, Self-care behaviors, Telephonic intervention, Diabetes, Nutrition, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored telephone intervention of educationBehavioural
Tailored telephone intervention to promote metabolic control of diabetes
Print educational interventionBehavioural
diabetes educational materials by mail
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tailored telephone intervention plus mailed print educational materials Receives: Behavioral: Tailored telephone intervention of education |
| 2 | Active comparator | print intervention with no telephone component Receives: Behavioral: Print educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Measured: 1 year
Metabolic control (measured by HbA1c)
Measured: 1 year
Secondary outcomes (2)
Changes in self-care behaviors including diet and exercise
Measured: 1 year
Cost evaluations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJul 2008
- Study completionJul 2008
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Elizabeth Walker, Albert Einstein College of Medicine
- Investigators
- Elizabeth A Walker, DNSc, RN, Principal investigator, Albert Einstein College of MedicineHillel W Cohen, DrPH, MPH, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179374
- Sponsor's protocol ID
- 2003-068
- Other IDs
- R18DK062038
- Status last verified
- Apr 2018
- First submitted
- 13 Sep 2005
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Medication Adherence and Outcomes
- ClinicalTrials.gov ID
- NCT00179374
- Acronym / sponsor ID
- 2003-068
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Medication adherence, Self-care behaviors, Telephonic intervention, Diabetes, Nutrition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Sep 2005 (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.
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care.
Detailed description
Metabolic control of type 2 diabetes and prevention of its complications are related to management of blood glucose and other factors. Medication and lifestyle modifications are integral to most self-management plans; however, adherence remains a great challenge. Many patients have abnormal HbA1c, blood pressure and lipid values, and are at greater risk for complications. This study is to evaluate the effectiveness and costs of a tailored, telephone intervention to promote adherence in middle-aged and older adults with type-2 diabetes who are members of a union/employer-sponsored health benefit plan. The target population includes English- and Spanish-speaking individuals from the health plan database.
This study has the following specific aims:
- A tailored telephone intervention will significantly improve medication adherence compared to a standard care intervention.
- A tailored telephone intervention will significantly improve metabolic control measured by HbA1c compared to a standard care intervention 2a) We will explore ways to link behavior change for medication adherence with lifestyle modification for diet and physical activity.
- To conduct cost evaluations for the telephone intervention vs. standard care. The study design is a randomized, controlled intervention trial with masking; the individual is the unit of sampling, assignment and analysis. After eligibility is assessed and consent is obtained by telephone, patients will be randomized to either the telephone intervention or standard are. Study outcomes will be medication adherence as measured from pharmacy records and metabolic control (HbA1c). A total of 556 patients with type 2 diabetes wil be randomized, which will provide 80% power to detect a statistically significant difference in HbA1c of at least 0.3%, and over 95% power to detect a difference in filled prescriptions. Telephone surveys will provide data on self-care behaviors including diet and exercise, risk perceptions, and depressive symptoms. Cost data will be collected using standardized methods. Study results will inform implementation of practical, nurse-managed interventions to improve medication adherence and metabolic control in diverse, middle-aged and older, type 2 diabetes patients, while linking changes in medication adherence to lifestyle modification for diet and physical activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Tailored telephone intervention of educationTailored telephone intervention plus mailed print educational materials |
| 2 | Active comparator | Behavioral: Print educational interventionprint intervention with no telephone component |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes
- Taking oral diabetes medication
- At least 40 years old
- In a union-sponsored health plan with full medication coverage for at least a year
- Able to understand English or Spanish
Key exclusion criteria (3 listed)
- Currently in a diabetes education program
- Will lose health care eligibility within a year
- Unable to receive phone calls or mail
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 |
|---|---|---|
| Tailored telephone intervention of educationTailored telephone intervention to promote metabolic control of diabetes | Behavioural | 1 |
| Print educational interventiondiabetes educational materials by mail | Behavioural | 2 |
Primary outcome
Medication adherence
Time frame: 1 year
Metabolic control (measured by HbA1c)
Time frame: 1 year
2 secondary outcomes
Changes in self-care behaviors including diet and exercise
Time frame: 1 year
Cost evaluations
Time frame: 1 year
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 26 Apr 2018.
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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.
Elizabeth A Walker, DNSc, RN principal investigator
Albert Einstein College of Medicine
Hillel W Cohen, DrPH, MPH principal investigator
Albert Einstein College of 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 Tailored telephone intervention of education and Print educational intervention in people with Diabetes Mellitus, Type 2, 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 26 Apr 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 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?
Medication adherence (time frame: 1 year). The study lists 2 primary outcomes in all. 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 26 Apr 2018.