OsteoarthritisNCT00386256

Home Telerehabilitation for Deconditioned Older Adults

A study testing Health Buddy, Home telehealth technology and Telephone counseling in people with Osteoarthritis, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Health Buddy, Home telehealth technology and Telephone counseling
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Jun 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

acute decline in functional status while hospitalized as reported by the patient
physically inactive outpatients (exercise less than 30 min/day, 3 d/wk)
ability to hear and communicate via telephone
ability to read a video or text monitor
ability to manually operate the technology
have a working telephone and power source
willingness to use the TEL-REHAB technology

Who cannot join

does not speak English
poor cognition as determined by the Mini-Cog
non-ambulatory
had a stroke, myocardial infarction, hip fracture, or total hip or knee replacement within the prior 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: Home Based Telerehabilitation for Deconditioned Older Adults

The purpose of this study is to develop a home exercise program for patients 60 years of age and over who are deconditioned following their discharge from the hospital, or recruited from GLA outpatient clinics. The program will be designed to monitor and improve patients' exercise behavior through the use of home technology, such as text messaging monitors.

Read the detailed description

The aim of this study is to develop and determine the feasibility of implementing a home exercise and functional status monitoring telerehabilitation program, known as TEL-REHAB, for older adults 60 years of age and over who are deconditioned following their discharge from the inpatient setting, or recruited from GLA outpatient clinics. Deconditioning is a modifiable risk factor for preventing institutionalization of frail elderly patients who would otherwise be able to live independently. Home exercise programs are an effective intervention to reduce the risk, but patient compliance with home exercise programs, and assessments of patients during home exercise programs, are barriers to achieving maximal benefits. Face-to-face visits with physical medicine professionals are an effective means to perform these functions, but are problematic because of professional time impacts and patient transportation problems. A TEL-REHAB program will empower these patients to take responsibility for their own health by providing ongoing communication with a healthcare provider. In this way, telerehabilitation may assist older adults to remain independent in their homes as long as possible.

Conditions: Osteoarthritis
Being tested: Health Buddy, Home telehealth technology, Telephone counseling
Keywords: telehealth, telerehabilitation, deconditioning, exercise
Medical subject headings: Osteoarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health Buddy, Home telehealth technologyDevice
Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
Telephone counselingOther

Study groups in NCT00386256
Study group	Role	What they receive
Health Buddy outpatient	Experimental	Received home telehealth monitoring by Health Buddy Receives: Device: Health Buddy, Home telehealth technology
Telephone outpatient	Experimental	Not described Receives: Other: Telephone counseling
health buddy inpatient	Experimental	Not described Receives: Device: Health Buddy, Home telehealth technology
telephone inpatient	Experimental	Not described Receives: Other: Telephone counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

Exercise Adherence
An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.
Measured: at monthly intervals, for 3-months
HB/Phone Adherence
An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.
Measured: Monthly over 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Jun 2008

First posted11 Oct 2006 (estimated)
Study startOct 2006
Primary completionMay 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00386256
Sponsor's protocol ID: E4204-R
Status last verified: Aug 2014
First submitted: 6 Oct 2006
Last updated: 15 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Harada ND, Dhanani S, Elrod M, Hahn T, Kleinman L, Fang M. Feasibility study of home telerehabilitation for physically inactive veterans. J Rehabil Res Dev. 2010;47(5):465-75. doi: 10.1682/jrrd.2009.09.0149.
PubMed 20803390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home Based Telerehabilitation for Deconditioned Older Adults
ClinicalTrials.gov ID: NCT00386256
Acronym / sponsor ID: E4204-R
Conditions: Osteoarthritis
Keywords: telehealth, telerehabilitation, deconditioning, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Oct 2006
Primary completion: May 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 11 Oct 2006 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Health Buddy outpatient	Experimental	Device: Health Buddy, Home telehealth technologyReceived home telehealth monitoring by Health Buddy
Telephone outpatient	Experimental	Other: Telephone counseling
health buddy inpatient	Experimental	Device: Health Buddy, Home telehealth technology
telephone inpatient	Experimental	Other: Telephone counseling

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

acute decline in functional status while hospitalized as reported by the patient
physically inactive outpatients (exercise less than 30 min/day, 3 d/wk)
ability to hear and communicate via telephone
ability to read a video or text monitor
ability to manually operate the technology

Key exclusion criteria (4 listed)

does not speak English
poor cognition as determined by the Mini-Cog
non-ambulatory
had a stroke, myocardial infarction, hip fracture, or total hip or knee replacement within the prior 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health Buddy, Home telehealth technologyExercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.	Device	Health Buddy outpatient, health buddy inpatient
Telephone counseling	Other	Telephone outpatient, telephone inpatient

Primary outcome

Exercise Adherence
Time frame: at monthly intervals, for 3-months
An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.
HB/Phone Adherence
Time frame: Monthly over 3 months
An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.

Results and safety

Results posted to the registry on 15 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Health Buddy Outpatient	16	16
Telephone Outpatient	15	15
Health Buddy Inpatient	4	4
Telephone Inpatient	3	3

Primary outcome: Exercise Adherence

Time frame: at monthly intervals, for 3-months. Mean (Standard Deviation). Unit: percentage of days adhered

Measure	Health Buddy Outpatient n = 16	Telephone Outpatient n = 15	Health Buddy Inpatient n = 4	Telephone Inpatient n = 3
Value	57.4 (24.9)	32.1 (22.7)	56.2 (15.6)	35.1 (20.0)

Health Buddy Outpatient vs Telephone Outpatient vs Health Buddy Inpatient vs Telephone Inpatient: p <.05, t-test, 2 sided

Primary outcome: HB/Phone Adherence

Time frame: Monthly over 3 months. Mean (Standard Deviation). Unit: percentage of days adhered

Measure	Health Buddy Outpatient n = 16	Telephone Outpatient n = 15	Health Buddy Inpatient n = 4	Telephone Inpatient n = 3
Value	64.7 (29.7)	36.3 (24.2)	70.1 (26.3)	43.7 (25.8)

Health Buddy Outpatient vs Telephone Outpatient vs Health Buddy Inpatient vs Telephone Inpatient: p <.05, t-test, 2 sided

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Health Buddy Outpatient	0 of 16 (0%)	4 of 16 (25%)	Not reported
Telephone Outpatient	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Health Buddy Inpatient	0 of 4 (0%)	3 of 4 (75%)	Not reported
Telephone Inpatient	0 of 3 (0%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): Intervention was developed on a male Veteran population, direct comparisons between groups were formed based on the participant's preference, exercise adherence was based on participants' self reports, small convenience sample.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20803390Harada ND, Dhanani S, Elrod M, Hahn T, Kleinman L, Fang M. Feasibility study of home telerehabilitation for physically inactive veterans. J Rehabil Res Dev. 2010;47(5):465-75. doi: 10.1682/jrrd.2009.09.0149.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy D. Harada, PhD MPA principal investigator

VA Greater Los Angeles Healthcare System, West LA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Health Buddy, Home telehealth technology and Telephone counseling in people with Osteoarthritis, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Adherence (time frame: at monthly intervals, for 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00386256, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.