Improving Diabetes Care Via Telephone Assessment and Patient Education
NCT ID: NCT00012649
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
480 participants
OBSERVATIONAL
2003-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits
NCT02522494
Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
NCT02953262
The Mobile Health and Wellness Program Remote Health Study
NCT07075978
Effectiveness of Home-Based Health Messaging for Patients With Hypertension and Diabetes
NCT00119054
Automated Diabetes Prevention Program
NCT00384488
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John D. Piette, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Rodney A. Hayward, MD
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Schillinger 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.
Piette JD. Enhancing support via interactive technologies. Curr Diab Rep. 2002 Apr;2(2):160-5. doi: 10.1007/s11892-002-0076-4.
Piette 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.
Piette 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.
Heisler 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.
Piette 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.
Piette 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.
Piette 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.
McKellar 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.
Piette 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DII 99-187
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.