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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Hypertension
Behavioral: In Home Health Messaging Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effectiveness of Care Coordination in Managing Medically Complex Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Blood Pressure and Hemaglobin A1c [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge Compliance Self-efficacy Quality of life Satisfaction with care [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: September 2005
Study Completion Date: December 2007
Arms Assigned Interventions
Arm 1 Behavioral: In Home Health Messaging Device

Detailed Description:

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119054

Locations
United States, Iowa
Iowa City VA Medical Center
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Investigators
Principal Investigator: Bonnie J. Wakefield, PhD RN Iowa City VA Medical Center
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00119054     History of Changes
Other Study ID Numbers: NRI 03-312
Study First Received: July 1, 2005
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hypertension
Diabetes Mellitus
Telemedicine
Nursing Care

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014