Diabetes Telemedicine Project

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00119041
First received: July 1, 2005
Last updated: April 15, 2014
Last verified: April 2014

July 1, 2005
April 15, 2014
September 2005
December 2007   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00119041 on ClinicalTrials.gov Archive Site
Patient A1c [ Time Frame: Will be measured at baseline and then after the active intervention phase ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Diabetes Telemedicine Project
Diabetes Telemedicine Consultation: A Systems Improvement Intervention

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.

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 objective of this study was to evaluate and document the processes of outreach consultation through the use of joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consisted 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 16-month intervention was assessed based on patients who were involved in the telemedicine clinic and those who were referred to a specialist to be seen on-site at the Cleveland VAMC.

Methods:

Study settings include the CBOCs affiliated with the Cleveland VAMC and involve primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria patients(N=282) included: (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 l or Type II diabetes will be included. Patients referred will be contacted and asked to participate.

Status:

Additional analyses are being conducted on health care costs and on impact beyond the patients directly involved in the study. Manuscripts are being prepared.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Diabetes Mellitus Type 2
  • Diabetes Mellitus, Type 1
  • 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.
  • Experimental: Arm 1
    Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
    Interventions:
    • Behavioral: The Diabetes Treatment Satisfaction Questionnaire
    • Behavioral: Diabetes Empowerment Scale
    • Behavioral: CBOC's undergo half-day joint-clinics via teleconference
  • No Intervention: Arm 2
    The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
December 2008
December 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00119041
IIR 03-254
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: David C Aron, MD MS Louis Stokes VA Medical Center
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP