DiabetesNCT00012649
Improving Diabetes Care Via Telephone Assessment and Patient Education
An observational study of Diabetes, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management (ATDM) system that administers patient assessments and targeted self-care education between clinic visits. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- How many people
- 480 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento May 2003
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients enrolled in VISN 12 and VISN 21
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management (ATDM) system that administers patient assessments and targeted self-care education between clinic visits.
Read the detailed description
Background:
The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management (ATDM) system that administers patient assessments and targeted self-care education between clinic visits.
Objectives:
In this ongoing study, we are determining: 1) the reliability and validity of Automated Telephone Disease Management (ATDM) assessments of patients' glycemic control, health-related quality of life (HRQL), self-care, and satisfaction with care; 2) the extent to which these assessments identify patients at risk for poor outcomes; and 3) the cost-effectiveness of an intervention in which ATDM assessment reports are provided regularly to patients' primary care providers.
Methods:
We are refining and expanding previously-developed ATDM assessment instruments by incorporating measures of patient-centered outcomes. We are enrolling 450 patients from VISN 12 and VISN 21. Patients receive weekly ATDM assessments for six months. Other data on their health status and service use are being collected from medical records, laboratory tests, telephone surveys, and Austin Automation Center files. After determining the concurrent reliability, validity, and prognostic significance of the ATDM assessments, we will examine variation in ATDM-reported outcomes across Networks, facilities, and patient groups. In the second phase of the study, we will conduct an effectiveness trial with a one year follow up period. We will use the findings from our process evaluation to modify the ATDM assessments and design provider feedback reports. We will enroll 240 patients from the two Networks (i.e., 480 patients overall). Patients will be assigned to experimental or usual care control groups using a combination of randomization and cutoff-based assignment. We will measure the intervention's impact on patients' glycemic control, symptoms, self-care, and patient-centered outcomes. We will use VA costing database and Medicare claims files to evaluate cost-effectiveness.
Status:
Analyses of ATDM assessment data suggest that this method is feasible with VA diabetes patients and provides comparable data regarding patients' satisfaction with care and functioning to telephone surveys. Other analysis suggest that VA interpersonal processes of care and rates of cost-related medication adherence problems are as good or better than that experienced by patients with comparable characteristics treated in other systems of care.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John D. Piette, PhD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MIRodney A. Hayward, MD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012649
- Sponsor's protocol ID
- DII 99-187
- Status last verified
- Jan 2005
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Heisler M, Piette JD. "I help you, and you help me": facilitated telephone peer support among patients with diabetes. Diabetes Educ. 2005 Nov-Dec;31(6):869-79. doi: 10.1177/0145721705283247.
PubMed 16288094Schillinger D, Piette J, Grumbach K, Wang F, Wilson C, Daher C, Leong-Grotz K, Castro C, Bindman AB. Closing the loop: physician communication with diabetic patients who have low health literacy. Arch Intern Med. 2003 Jan 13;163(1):83-90. doi: 10.1001/archinte.163.1.83.
PubMed 12523921Piette JD. Enhancing support via interactive technologies. Curr Diab Rep. 2002 Apr;2(2):160-5. doi: 10.1007/s11892-002-0076-4.
PubMed 12643135Piette JD, Schillinger D, Potter MB, Heisler M. Dimensions of patient-provider communication and diabetes self-care in an ethnically diverse population. J Gen Intern Med. 2003 Aug;18(8):624-33. doi: 10.1046/j.1525-1497.2003.31968.x.
PubMed 12911644Piette JD, Richardson C, Valenstein M. Addressing the needs of patients with multiple chronic illnesses: the case of diabetes and depression. Am J Manag Care. 2004 Feb;10(2 Pt 2):152-62.
PubMed 15005508Heisler M, Wagner TH, Piette JD. Clinician identification of chronically ill patients who have problems paying for prescription medications. Am J Med. 2004 Jun 1;116(11):753-8. doi: 10.1016/j.amjmed.2004.01.013.
PubMed 15144912Piette JD, Heisler M, Wagner TH. Problems paying out-of-pocket medication costs among older adults with diabetes. Diabetes Care. 2004 Feb;27(2):384-91. doi: 10.2337/diacare.27.2.384.
PubMed 14747218Piette JD, Wagner TH, Potter MB, Schillinger D. Health insurance status, cost-related medication underuse, and outcomes among diabetes patients in three systems of care. Med Care. 2004 Feb;42(2):102-9. doi: 10.1097/01.mlr.0000108742.26446.17.
PubMed 14734946Piette JD, Heisler M, Wagner TH. Cost-related medication underuse among chronically ill adults: the treatments people forgo, how often, and who is at risk. Am J Public Health. 2004 Oct;94(10):1782-7. doi: 10.2105/ajph.94.10.1782.
PubMed 15451750McKellar JD, Humphreys K, Piette JD. Depression increases diabetes symptoms by complicating patients' self-care adherence. Diabetes Educ. 2004 May-Jun;30(3):485-92. doi: 10.1177/014572170403000320.
PubMed 15208846Piette JD, Heisler M, Wagner TH. Cost-related medication underuse: do patients with chronic illnesses tell their doctors? Arch Intern Med. 2004 Sep 13;164(16):1749-55. doi: 10.1001/archinte.164.16.1749.
PubMed 15364667
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Care Via Telephone Assessment and Patient Education
- ClinicalTrials.gov ID
- NCT00012649
- Acronym / sponsor ID
- DII 99-187
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- May 2003 (actual)
- First posted
- 16 Mar 2001 (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 purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management (ATDM) system that administers patient assessments and targeted self-care education between clinic visits.
Detailed description
Background:
The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management (ATDM) system that administers patient assessments and targeted self-care education between clinic visits.
Objectives:
In this ongoing study, we are determining: 1) the reliability and validity of Automated Telephone Disease Management (ATDM) assessments of patients' glycemic control, health-related quality of life (HRQL), self-care, and satisfaction with care; 2) the extent to which these assessments identify patients at risk for poor outcomes; and 3) the cost-effectiveness of an intervention in which ATDM assessment reports are provided regularly to patients' primary care providers.
Methods:
We are refining and expanding previously-developed ATDM assessment instruments by incorporating measures of patient-centered outcomes. We are enrolling 450 patients from VISN 12 and VISN 21. Patients receive weekly ATDM assessments for six months. Other data on their health status and service use are being collected from medical records, laboratory tests, telephone surveys, and Austin Automation Center files. After determining the concurrent reliability, validity, and prognostic significance of the ATDM assessments, we will examine variation in ATDM-reported outcomes across Networks, facilities, and patient groups. In the second phase of the study, we will conduct an effectiveness trial with a one year follow up period. We will use the findings from our process evaluation to modify the ATDM assessments and design provider feedback reports. We will enroll 240 patients from the two Networks (i.e., 480 patients overall). Patients will be assigned to experimental or usual care control groups using a combination of randomization and cutoff-based assignment. We will measure the intervention's impact on patients' glycemic control, symptoms, self-care, and patient-centered outcomes. We will use VA costing database and Medicare claims files to evaluate cost-effectiveness.
Status:
Analyses of ATDM assessment data suggest that this method is feasible with VA diabetes patients and provides comparable data regarding patients' satisfaction with care and functioning to telephone surveys. Other analysis suggest that VA interpersonal processes of care and rates of cost-related medication adherence problems are as good or better than that experienced by patients with comparable characteristics treated in other systems of care.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients enrolled in VISN 12 and VISN 21
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 16288094Heisler M, Piette JD. "I help you, and you help me": facilitated telephone peer support among patients with diabetes. Diabetes Educ. 2005 Nov-Dec;31(6):869-79. doi: 10.1177/0145721705283247.
- Results publication: PubMed 12523921Schillinger D, Piette J, Grumbach K, Wang F, Wilson C, Daher C, Leong-Grotz K, Castro C, Bindman AB. Closing the loop: physician communication with diabetic patients who have low health literacy. Arch Intern Med. 2003 Jan 13;163(1):83-90. doi: 10.1001/archinte.163.1.83.
- Results publication: PubMed 12643135Piette JD. Enhancing support via interactive technologies. Curr Diab Rep. 2002 Apr;2(2):160-5. doi: 10.1007/s11892-002-0076-4.
- Results publication: PubMed 12911644Piette JD, Schillinger D, Potter MB, Heisler M. Dimensions of patient-provider communication and diabetes self-care in an ethnically diverse population. J Gen Intern Med. 2003 Aug;18(8):624-33. doi: 10.1046/j.1525-1497.2003.31968.x.
- Results publication: PubMed 15005508Piette JD, Richardson C, Valenstein M. Addressing the needs of patients with multiple chronic illnesses: the case of diabetes and depression. Am J Manag Care. 2004 Feb;10(2 Pt 2):152-62.
- Results publication: PubMed 15144912Heisler M, Wagner TH, Piette JD. Clinician identification of chronically ill patients who have problems paying for prescription medications. Am J Med. 2004 Jun 1;116(11):753-8. doi: 10.1016/j.amjmed.2004.01.013.
- Results publication: PubMed 14747218Piette JD, Heisler M, Wagner TH. Problems paying out-of-pocket medication costs among older adults with diabetes. Diabetes Care. 2004 Feb;27(2):384-91. doi: 10.2337/diacare.27.2.384.
- Results publication: PubMed 14734946Piette JD, Wagner TH, Potter MB, Schillinger D. Health insurance status, cost-related medication underuse, and outcomes among diabetes patients in three systems of care. Med Care. 2004 Feb;42(2):102-9. doi: 10.1097/01.mlr.0000108742.26446.17.
- Results publication: PubMed 15451750Piette JD, Heisler M, Wagner TH. Cost-related medication underuse among chronically ill adults: the treatments people forgo, how often, and who is at risk. Am J Public Health. 2004 Oct;94(10):1782-7. doi: 10.2105/ajph.94.10.1782.
- Results publication: PubMed 15208846McKellar JD, Humphreys K, Piette JD. Depression increases diabetes symptoms by complicating patients' self-care adherence. Diabetes Educ. 2004 May-Jun;30(3):485-92. doi: 10.1177/014572170403000320.
- Results publication: PubMed 15364667Piette JD, Heisler M, Wagner TH. Cost-related medication underuse: do patients with chronic illnesses tell their doctors? Arch Intern Med. 2004 Sep 13;164(16):1749-55. doi: 10.1001/archinte.164.16.1749.
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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.
John D. Piette, PhD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Rodney A. Hayward, MD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by US Department of Veterans Affairs at 4 sites 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 1 inclusion and 0 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00012649, which also lists 11 linked publications.
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 7 Apr 2015.