Trial Outcomes & Findings for Home Telerehabilitation for Deconditioned Older Adults (NCT NCT00386256)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

at monthly intervals, for 3-months

Results posted on

2014-08-15

Participant Flow

Subjects were recruited from both the inpatient and outpatient settings of a large urban academic VA hospital. Potential participants were recruited through referrals from physicians, case managers, and social workers, participant recruitment fairs, and flyers posted around the hospital.

Participant milestones

Participant milestones
Measure	Health Buddy Outpatient Health Buddy(R), Home telehealth technology : 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 Outpatient	Health Buddy Inpatient	Telephone Inpatient
Overall Study STARTED	16	15	4	3
Overall Study COMPLETED	16	15	4	3
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home Telerehabilitation for Deconditioned Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Buddy Outpatient n=16 Participants Received Health Buddy, recruited from outpatient setting	Telephone Outpatient n=15 Participants Received telephone counseling, recruited from outpatient setting	Health Buddy Inpatient n=4 Participants Received Health Buddy, recruited from inpatient setting	Telephone Inpatient n=3 Participants Received telephone counseling, recruited from inpatient setting	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	36 Participants n=21 Participants
Age, Continuous	69.9 years STANDARD_DEVIATION 7.9 • n=5 Participants	65 years STANDARD_DEVIATION 6.1 • n=7 Participants	78 years STANDARD_DEVIATION 4.7 • n=5 Participants	76 years STANDARD_DEVIATION 7.5 • n=4 Participants	72.2 years STANDARD_DEVIATION 6.6 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	38 Participants n=21 Participants
Region of Enrollment United States	16 participants n=5 Participants	15 participants n=7 Participants	4 participants n=5 Participants	3 participants n=4 Participants	38 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Buddy Outpatient n=16 Participants Received Health Buddy, recruited from outpatient setting	Telephone Outpatient n=15 Participants Received telephone counseling, recruited from outpatient setting	Health Buddy Inpatient n=4 Participants Received Health Buddy, recruited from inpatient setting	Telephone Inpatient n=3 Participants Received telephone counseling, recruited from inpatient setting
Exercise Adherence	57.4 percentage of days adhered Standard Deviation 24.9	32.1 percentage of days adhered Standard Deviation 22.7	56.2 percentage of days adhered Standard Deviation 15.6	35.1 percentage of days adhered Standard Deviation 20.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Buddy Outpatient n=16 Participants Received Health Buddy, recruited from outpatient setting	Telephone Outpatient n=15 Participants Received telephone counseling, recruited from outpatient setting	Health Buddy Inpatient n=4 Participants Received Health Buddy, recruited from inpatient setting	Telephone Inpatient n=3 Participants Received telephone counseling, recruited from inpatient setting
HB/Phone Adherence	64.7 percentage of days adhered Standard Deviation 29.7	36.3 percentage of days adhered Standard Deviation 24.2	70.1 percentage of days adhered Standard Deviation 26.3	43.7 percentage of days adhered Standard Deviation 25.8

Adverse Events

Health Buddy Outpatient

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Telephone Outpatient

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Health Buddy Inpatient

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Telephone Inpatient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Health Buddy Outpatient n=16 participants at risk Received Health Buddy, recruited from outpatient setting	Telephone Outpatient n=15 participants at risk Received telephone counseling, recruited from outpatient setting	Health Buddy Inpatient n=4 participants at risk Received Health Buddy, recruited from inpatient setting	Telephone Inpatient n=3 participants at risk Received telephone counseling, recruited from inpatient setting
General disorders Chest tightness	12.5% 2/16 • Number of events 4 • 3 months	6.7% 1/15 • Number of events 1 • 3 months	50.0% 2/4 • Number of events 2 • 3 months	0.00% 0/3 • 3 months
General disorders Dizziness	12.5% 2/16 • Number of events 4 • 3 months	0.00% 0/15 • 3 months	50.0% 2/4 • Number of events 2 • 3 months	0.00% 0/3 • 3 months
General disorders Trips/Falls	25.0% 4/16 • Number of events 4 • 3 months	0.00% 0/15 • 3 months	25.0% 1/4 • Number of events 1 • 3 months	0.00% 0/3 • 3 months

Additional Information

Nancy Harada, PhD

VA Greater Los Angeles Healthcare System

Phone: 310-268-3632

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place