Trial Outcomes & Findings for Veterans Walk to Beat Back Pain (NCT NCT00694018)
NCT ID: NCT00694018
Last Updated: 2015-04-27
Results Overview
The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
229 participants
Primary outcome timeframe
12 months
Results posted on
2015-04-27
Participant Flow
Participant milestones
| Measure |
Education and Standard Care
Education and standard care: Educational program for individuals with chronic back pain.
|
Internet Mediated Enhanced Pedometer
Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
111
|
|
Overall Study
6 Months
|
106
|
101
|
|
Overall Study
COMPLETED
|
105
|
102
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Veterans Walk to Beat Back Pain
Baseline characteristics by cohort
| Measure |
Education and Standard Care
n=118 Participants
Education and standard care: Educational program for individuals with chronic back pain.
|
Internet Mediated Enhanced Pedometer
n=111 Participants
Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
51.2 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
51.5 years
STANDARD_DEVIATION 12.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
201 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
101 participants
n=99 Participants
|
82 participants
n=107 Participants
|
183 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 participants
n=99 Participants
|
14 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other or prefer not to answer
|
6 participants
n=99 Participants
|
15 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=99 Participants
|
111 participants
n=107 Participants
|
229 participants
n=206 Participants
|
|
Roland Morris Disability Questionnaire (RDQ) Score
|
9.8 units on a scale
STANDARD_DEVIATION 5.7 • n=99 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 6.0 • n=107 Participants
|
9.5 units on a scale
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Daily step counts
|
4321.9 steps
STANDARD_DEVIATION 2285.4 • n=99 Participants
|
4492.9 steps
STANDARD_DEVIATION 2749.9 • n=107 Participants
|
4404.8 steps
STANDARD_DEVIATION 2517.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed is slightly lower than the number who completed the study at 12 months due to item non-response on the final study survey
The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability
Outcome measures
| Measure |
Education and Standard Care
n=103 Participants
Education and standard care: Educational program for individuals with chronic back pain.
|
Internet Mediated Enhanced Pedometer
n=102 Participants
Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
|
|---|---|---|
|
The Roland Morris Disability Questionnaire (RDQ) Score
|
8.3 units on a scale
Standard Deviation 5.6
|
6.6 units on a scale
Standard Deviation 5.9
|
Adverse Events
Education and Standard Care
Serious events: 26 serious events
Other events: 76 other events
Deaths: 0 deaths
Internet Mediated Enhanced Pedometer
Serious events: 27 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Education and Standard Care
n=118 participants at risk
Education and standard care: Educational program for individuals with chronic back pain.
|
Internet Mediated Enhanced Pedometer
n=111 participants at risk
Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
|
|---|---|---|
|
General disorders
All serious adverse events
|
22.0%
26/118 • During the 1 year intervention period
Participants reported any health problems whether or not study related as prompted by weekly (intervention) or monthly (control) emails. After the first four weeks and then every eight weeks after that, all participants were prompted to complete a survey on the website that asked about specific adverse events and symptoms.
|
24.3%
27/111 • During the 1 year intervention period
Participants reported any health problems whether or not study related as prompted by weekly (intervention) or monthly (control) emails. After the first four weeks and then every eight weeks after that, all participants were prompted to complete a survey on the website that asked about specific adverse events and symptoms.
|
Other adverse events
| Measure |
Education and Standard Care
n=118 participants at risk
Education and standard care: Educational program for individuals with chronic back pain.
|
Internet Mediated Enhanced Pedometer
n=111 participants at risk
Education and standard care: Educational program for individuals with chronic back pain.
Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.
|
|---|---|---|
|
General disorders
All (non-serious) adverse events
|
64.4%
76/118 • During the 1 year intervention period
Participants reported any health problems whether or not study related as prompted by weekly (intervention) or monthly (control) emails. After the first four weeks and then every eight weeks after that, all participants were prompted to complete a survey on the website that asked about specific adverse events and symptoms.
|
78.4%
87/111 • During the 1 year intervention period
Participants reported any health problems whether or not study related as prompted by weekly (intervention) or monthly (control) emails. After the first four weeks and then every eight weeks after that, all participants were prompted to complete a survey on the website that asked about specific adverse events and symptoms.
|
Additional Information
Sarah L. Krein, PhD, RN
VA Ann Arbor Center for Clinical Management Research
Phone: 734-845-3621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place