NCT00694018

Brief Summary

The objective of this study was to assess whether an Internet-mediated pedometer based intervention would increase walking and improve function among individuals with chronic back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 17, 2014

Completed
Last Updated

April 27, 2015

Status Verified

September 1, 2014

Enrollment Period

2.7 years

First QC Date

May 28, 2008

Results QC Date

October 6, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

randomized trialwalking

Outcome Measures

Primary Outcomes (1)

  • The Roland Morris Disability Questionnaire (RDQ) Score

    The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability

    12 months

Study Arms (2)

Education and Standard Care

ACTIVE COMPARATOR

Received standard care and participated in an educational program for individuals with chronic back pain. Also received an uploading pedometer but no feedback or goals about their walking activity.

Other: Education and standard care

Internet Mediated Enhanced Pedometer

EXPERIMENTAL

In addition to standard care and participating in an educational program, participants received an enhanced pedometer for uploading step information, e-mail messages with weekly step goals and access to a website that provided step goals and feedback, tailored motivational messages and on on-line community for communication asynchronously with staff and other participants.

Other: Education and standard careBehavioral: Internet mediated enhanced pedometer intervention

Interventions

Educational program for individuals with chronic back pain.

Education and Standard CareInternet Mediated Enhanced Pedometer

Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community.

Internet Mediated Enhanced Pedometer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans receiving care at the VA Ann Arbor Healthcare System
  • Have back pain that has persisted for more than 3 months
  • Have a sedentary lifestyle (less than 150 minutes of physical activity per week)
  • Have access to a computer (with Windows XP or Vista) on at least a weekly basis with an available USB port and Internet access
  • Have a working e-mail address
  • Are competent to provide written informed consent
  • Are able to communicate in English
  • Are not institutionalized
  • Can identify a health care provider who can provide medical clearance.

You may not qualify if:

  • Currently pregnant
  • Cannot walk at least one block
  • Cannot obtain written clearance to start a walking program from a treating healthcare provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (3)

  • Krein SL, Kadri R, Hughes M, Kerr EA, Piette JD, Holleman R, Kim HM, Richardson CR. Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial. J Med Internet Res. 2013 Aug 19;15(8):e181. doi: 10.2196/jmir.2605.

  • Krein SL, Metreger T, Kadri R, Hughes M, Kerr EA, Piette JD, Kim HM, Richardson CR. Veterans walk to beat back pain: study rationale, design and protocol of a randomized trial of a pedometer-based internet mediated intervention for patients with chronic low back pain. BMC Musculoskelet Disord. 2010 Sep 13;11:205. doi: 10.1186/1471-2474-11-205.

  • Krein SL, Bohnert A, Kim HM, Harris ME, Richardson CR. Opioid use and walking among patients with chronic low back pain. J Rehabil Res Dev. 2016;53(1):107-16. doi: 10.1682/JRRD.2014.08.0190.

MeSH Terms

Conditions

Back Pain

Interventions

Educational StatusStandard of Care

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Sarah L. Krein, PhD, RN
Organization
VA Ann Arbor Center for Clinical Management Research

Study Officials

  • Sarah L. Krein, PhD RN

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 10, 2008

Study Start

May 1, 2009

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

April 27, 2015

Results First Posted

October 17, 2014

Record last verified: 2014-09

Locations