Diabetes Telemedicine Project

/Home/Diabetes Treatment/Diabetes Clinical Trials - Active Not Recruiting

Diabetes Telemedicine Project

This study is ongoing, but not recruiting participants.

Sponsored by: Department of Veterans Affairs

Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00119041

Purpose
This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs.



Condition Intervention
Diabetes Mellitus Type 2
Diabetes Mellitus, Type 1
Behavioral: The Diabetes Treatment Satisfaction Questionnaire
Behavioral: Diabetes Empowerment Scale
Behavioral: CBOC's undergo half-day joint-clinics via teleconference



MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type: Interventional
Study Design: Other, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

Official Title: Diabetes Telemedicine Consultation: A Systems Improvement Intervention


Further study details as provided by Department of Veterans Affairs:


Primary Outcome Measures:
The outcomes for this study are patient satisfaction and self-efficacy. Both outcomes will be measured at baseline and then after the intervention at 18 months. [ Time Frame: 18 months ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
Patient A1c [ Time Frame: Will be measured at baseline and then after the active intervention phase ] [ Designated as safety issue: No ]


Enrollment: 268
Study Start Date: September 2005
Estimated Study Completion Date: June 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)


Arms Assigned Interventions
1: Experimental
Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit. Behavioral: The Diabetes Treatment Satisfaction Questionnaire
A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Behavioral: Diabetes Empowerment Scale
A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
Behavioral: CBOC's undergo half-day joint-clinics via teleconference
A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
2: No Intervention
The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.


Detailed Description:
Background:

Diabetes is a national problem that has reached epidemic proportions, according to the U.S. Centers for Disease Control and Prevention. Diabetes has particular importance for the Department of Veterans Affairs (VA) because the prevalence among VA patients -- one in six, or 16 percent -- is substantially higher than in the general population.

Objectives:

The immediate objective is to evaluate and document the processes of outreach consultation through using joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consists of a teleconferenced joint-clinic consultation session involving the patient, Diabetes Specialist Team, the PCP and other relevant care team members. The impact of the intervention will be assessed using both high-risk patients who are referred to a diabetes specialist for consultation during the 18-month active intervention phase (Cohort I) and other patients with diabetes who are not referred during the intervention phase (Cohort II). The specific aims are:

compare the impact of diabetes specialist joint-clinic consultations via teleconferencing conducted at CBOCs to the usual consultation process on referred high-risk Cohort I patients and providers;
compare the impact of diabetes joint-clinic consultations via teleconferencing to usual consultation process on outcomes related to providers' care of other patients (non-Cohort I patients);
compare processes and change in processes associated with diabetes specialist joint-clinic consultations to usual outpatient consultation process for patients with diabetes using qualitative and quantitative methods (microsystem factors);
evaluate short-term medical care utilization and costs associated with the intervention.
The long-term objectives are to improve the quality of care delivered and decrease diabetes-related complications.

Methods:

Study settings include the CBOCs and involves primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria for Cohort I patients are: (i) current prescription of insulin or an oral hypoglycemic agent; (ii) A1c > 7.0%; or (iii) fasting glucose levels > 130 mg/dl; and (iv) referred to see a consultant (beginning three months prior to the active intervention phase and continuing through enrollment for the last month of the active intervention phase). Patients with either Type I or Type II diabetes will be included. Patients referred will be contacted and asked to participate (N=710 anticipated to complete the study). Cohort II patients will be determined by the above criteria minus referral (N=10,270). All PCP/PC CBOC team members (N=90) and CBOC staff involved in the care of patients will be asked to participate.

Status:

Provider and patient enrollment began in August, 2005. Subsequently, joint-clinic consultations began in September, 2005. Active patient enrollment ended June of 2007. Data is still being collected on enrolled patients and providers.

Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1) Current prescription of insulin or an oral hypoglycemic agent; 2) A1c > 7.0%; or 3) fasting glucose levels > 130 mg/dl; and 4) referred to see a consultant and are seen during the active intervention phase. Patients with either Type I or Type II DM will be included.

Exclusion Criteria:

1) primary care obtained at more than one site (based on stop codes with evidence of more than 1 CBOC involved in care during the last 6 months), and 2) documented dementia, aphasia, and psychosis.

Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier: NCT00119041

Locations


United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170

United States, Ohio
Louis Stokes VA Medical Center
Cleveland, Ohio, United States, 44106-3800


Sponsors and Collaborators


Department of Veterans Affairs


Investigators


Principal Investigator: David C. Aron, MD MS Louis Stokes VA Medical Center

More Information

Responsible Party: Department of Veterans Affairs ( Aron, David - Principal Investigator )
Study ID Numbers: IIR 03-254
First Received: July 1, 2005
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00119041
Health Authority: United States: Federal Government


Keywords provided by Department of Veterans Affairs:
Diabetes Mellitus
Telemedicine
Referral
Consultation



Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders



Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Immune System Diseases
Diabetes Mellitus, Type 2
Endocrine System Diseases
Nutritional and Metabolic Diseases
Diabetes Mellitus


ClinicalTrials.gov processed this record on June 11, 2008