Effectiveness of Home-Based Health Messaging for Patients With Hypertension and Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00119054
First received: July 1, 2005
Last updated: April 25, 2014
Last verified: April 2014

July 1, 2005
April 25, 2014
September 2005
Not Provided
Blood Pressure and Hemaglobin A1c [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00119054 on ClinicalTrials.gov Archive Site
Knowledge Compliance Self-efficacy Quality of life Satisfaction with care [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effectiveness of Home-Based Health Messaging for Patients With Hypertension and Diabetes
Effectiveness of Care Coordination in Managing Medically Complex Patients

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.

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.The primary objective of the proposed study is to evaluate the efficacy of care coordination in improving outcomes in veterans with co-morbid DM and HTN, the two most common chronic conditions seen in VA Primary Care clinics. The specific aim is to compare outcomes of patients who receive the care coordination intervention to outcomes of patients who receive usual care. Three hypotheses will be tested: Compared to subjects who receive usual care, subjects who receive the care coordination intervention will have: 1) improved clinical measures [hemoglobin A1c (HbA1c) and systolic blood pressure (SBP)] at 6 and 12 months after study enrollment; 2) improved disease self-management (knowledge, self-efficacy, and adherence) at 6 and 12 months after study enrollment; and 3) improved quality of life and satisfaction with care at 6 and 12 months after study enrollment.Subjects wererecruited from VA Primary Care clinic rolls. 302 subjects were randomized to three groups: low-intensity monitoring plus nurse care management intervention (n=102); high-intensity monitoring plus nurse care management intervention (n=93); and usual care (n=107). In both intervention groups patients transmitted vital signs daily. In addition, the low intensity group answered two general health questions; the high intensity group responded to a complete range of questions focused on diabetes and hypertension, and received educational tips. The intervention groups participated in the protocol for 6 months following enrollment. Data were collected at baseline and at 6 and 12 months, including measures of clinical outcomes, quality of life, knowledge, adherence, self-efficacy, and satisfaction with care. In addition to these measures, data were collected to estimate the cost of the home telehealth intervention. Most subjects were male (98%) Caucasians (96%) with a mean age of 68 years (range 40-89 years).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Diabetes Mellitus
  • Hypertension
Behavioral: In Home Health Messaging Device
Arm 1
Intervention: Behavioral: In Home Health Messaging Device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
December 2007
Not Provided

Inclusion Criteria:

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.

Exclusion Criteria:

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00119054
NRI 03-312
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Bonnie J. Wakefield, PhD RN Iowa City 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