- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105846
An Evaluation of Home-Based Telemedicine Services
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.
Objectives:
The primary objectives were to determine if tele-home health care patients, compared with patients receiving usual home care, have:1) higher levels of health related quality of life and home care satisfaction; 2) fewer inpatient admissions, hospital stays, and outpatient and emergency room visits; and 3) higher levels of home care access, in terms of the total number of contacts between HBPC nurses and patients.
Methods:
Patients were randomly assigned to the intervention or to the control group. Video tele-health units were installed in patient homes for the intervention group, and control group patients received usual home care services. Baseline and six month follow up surveys included questions on perceived health related quality of life and home care satisfaction. T-tests were used to compare intervention and control group members in terms of six month changes in health related quality of life and satisfaction with home care. Multivariate analyses were used to assess group differences in six month health care service use, with prior service use and survival included as covariates.
Status:
The study is completed, with a final enrollment of 37 patients. Three study manuscrip[ts have been completed (two published and one under review).
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
-
Nebraska
-
Indianapolis, Nebraska, United States, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must be enrolled in the home care program at the Indianapolis VAMC and have at least: (a) 6 outpatient visits, one hospitalization, or 2 or more emergency room visits in the last twelve months, (b) a care plan specifying two or more skilled nursing visits per month, (c) an expected need for future home care visits for at least one month.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Faith P. Hopp, PhD MA MSW, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publications and helpful links
General Publications
- Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D, Lowery J. Outcomes associated with a home care telehealth intervention. Telemed J E Health. 2006 Jun;12(3):297-307. doi: 10.1089/tmj.2006.12.297.
- Subramanian U, Hopp F, Lowery J, Woodbridge P, Smith D. Research in home-care telemedicine: challenges in patient recruitment. Telemed J E Health. 2004 Summer;10(2):155-61. doi: 10.1089/tmj.2004.10.155.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEL 20-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of North Carolina, Chapel HillAmerican Diabetes AssociationNot yet recruitingType 2 Diabetes Mellitus (T2DM) | Diabetes (DM) | Insulin Dependent Diabetes | Type 1 Diabetes (T1D) | Diabetes Education | Diabetes Care | Diabetes (Insulin-requiring, Type 1 or Type 2)United States
-
University of Colorado, DenverMassachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of... and other collaboratorsRecruitingDiabetes Mellitus | Diabetes | Type 2 Diabetes | Diabetes Mellitus Type 2 | Diabetes Mellitus, Type I | Diabetes Mellitus Type II | Diabetes Mellitus, Insulin-Dependent | Diabetes, Autoimmune | Type 1 Diabetes (T1D) | Diabetes Type 2 on Insulin | Diabetes, Type IIUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of North Carolina, Chapel HillAmerican Heart AssociationRecruitingType 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes EducationUnited States
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Steno Diabetes Center CopenhagenNot yet recruitingDiabetes | Diabetes Type 1 | Diabetes Type 2 | Digital Health | Diabetes Care | Remote Patient MonitoringDenmark
-
COUR Pharmaceutical Development Company, Inc.RecruitingType 1 Diabetes | Type 1 Diabetes Mellitus | T1DM | T1D | Type 1 Diabetes in Adolescence | Type 1 Diabetes in Children | Type 1 Diabetes Patients | Type 1 Diabetes Mellitis | T1DM - Type 1 Diabetes Mellitus | Type 1 Diabetes (Juvenile Onset)United States
Clinical Trials on Home care telemedicine
-
Michele VitaccaFondazione Salvatore MaugeriCompleted
-
The University of Texas Health Science Center,...Texas Medical Center Health Policy InstituteCompletedChronic DiseaseUnited States
-
United States Department of DefenseCompleted
-
University of RochesterAgency for Healthcare Research and Quality (AHRQ)CompletedTelemedicine | Physical DisordersUnited States
-
Fondazione Salvatore MaugeriUnknownParkinson's Disease
-
Mayo ClinicNational Institute of Nursing Research (NINR)CompletedHeart Failure | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Stable Angina Pectoris | Acute Myocardial InfarctionUnited States
-
National Taiwan University HospitalNational Science and Technology Council, TaiwanNot yet recruitingDecompensated Cirrhosis of LiverTaiwan
-
NHS Greater Glasgow and ClydeUniversity of Strathclyde; Glasgow Royal InfirmaryNot yet recruiting
-
University of California, Los AngelesCompleted