NCT00119054

Brief Summary

Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic conditions. Two of the most common conditions in the VA population are hypertension (HTN) and Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily basis that motivate patients to comply with treatment recommendations and lifestyle changes. Thus, serious complications and long-term adverse outcomes are common in both of these conditions. Home telehealth is a general term used to describe the delivery of health care services to the patient's home using audio, video, or other telecommunications technologies. Although home telehealth offers a number of theoretical advantages, few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit. Furthermore, projects to date have focused on special populations, e.g., heart failure or mental illnesses. Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses, there is a need for population-based studies addressing the needs of patients in primary care settings. Care coordination, as defined by the VHA Office of Care Coordination, is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention, investigation, and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources. Care coordination embeds technology into a care management process. This results in the right care, at the right time, in the right place.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

January 1, 2008

First QC Date

July 1, 2005

Last Update Submit

April 6, 2015

Conditions

Keywords

HypertensionDiabetes MellitusTelemedicineNursing Care

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure and Hemaglobin A1c

Secondary Outcomes (1)

  • Knowledge Compliance Self-efficacy Quality of life Satisfaction with care

Study Arms (1)

Arm 1

OTHER
Behavioral: In Home Health Messaging Device

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must obtain their primary care at the Iowa City VAMC and have been diagnosed with Diabetes Mellitus and hypertension. Must be cognitively intact and have a telephone line in the home.

You may not qualify if:

  • Patients with corrected vision worse than 20/40 or cognitive impairment (Mini-Mental Status Exam score of 17 or less) will not be eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Related Publications (9)

  • Wakefield BJ, Holman JE, Ray A, Scherubel M, Adams MR, Hills SL, Rosenthal GE. Outcomes of a home telehealth intervention for patients with diabetes and hypertension. Telemed J E Health. 2012 Oct;18(8):575-9. doi: 10.1089/tmj.2011.0237. Epub 2012 Aug 8.

  • Wakefield BJ, Holman JE, Ray A, Scherubel M, Adams MR, Hillis SL, Rosenthal GE. Effectiveness of home telehealth in comorbid diabetes and hypertension: a randomized, controlled trial. Telemed J E Health. 2011 May;17(4):254-61. doi: 10.1089/tmj.2010.0176. Epub 2011 Apr 10.

  • Wakefield BJ, Holman JE, Ray A, Scherubel M. Patient perceptions of a remote monitoring intervention for chronic disease management. J Gerontol Nurs. 2011 Apr;37(4):16-20. doi: 10.3928/00989134-20110302-05. Epub 2011 Mar 16.

  • Young LB, Foster L, Silander A, Wakefield BJ. Home telehealth: patient satisfaction, program functions, and challenges for the care coordinator. J Gerontol Nurs. 2011 Nov;37(11):38-46. doi: 10.3928/00989134-20110706-02. Epub 2011 Jul 15.

  • Wakefield BJ, Scherubel M, Ray A, Holman JE. Nursing interventions in a telemonitoring program. Telemed J E Health. 2013 Mar;19(3):160-5. doi: 10.1089/tmj.2012.0098. Epub 2013 Jan 28.

  • Gardner SE, Hillis SL, Frantz RA. Clinical signs of infection in diabetic foot ulcers with high microbial load. Biol Res Nurs. 2009 Oct;11(2):119-28. doi: 10.1177/1099800408326169.

  • Boren SA, Wakefield BJ, Dohrmann M. Chronic heart failure consumer information: an exploratory study. AMIA Annu Symp Proc. 2008 Nov 6:884.

  • Wakefield BJ, Mentes J, Holman JE, Culp K. Postadmission dehydration: risk factors, indicators, and outcomes. Rehabil Nurs. 2009 Sep-Oct;34(5):209-16. doi: 10.1002/j.2048-7940.2009.tb00281.x.

  • Rantz MJ, Skubic M, Alexander G, Popescu M, Aud MA, Wakefield BJ, Koopman RJ, Miller SJ. Developing a comprehensive electronic health record to enhance nursing care coordination, use of technology, and research. J Gerontol Nurs. 2010 Jan;36(1):13-7. doi: 10.3928/00989134-20091204-02. Epub 2010 Jan 12.

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bonnie J. Wakefield, PhD RN

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 12, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2007

Last Updated

April 7, 2015

Record last verified: 2008-01

Locations