Stepping up to Health - for Veterans With Chronic Obstructive Pulmonary Disease (COPD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01102777
First received: April 9, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess the efficacy of an internet-mediated pedometer based intervention that is designed to increase walking and improve function among veterans with chronic obstructive pulmonary disease (COPD). The Specific Aims are: 1) to test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health-related quality of life at four-months and at one year in a randomized controlled trial (RCT) with a wait list control. 2) to estimate the effect of internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization. 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm. The long-term objective of this research is to develop, evaluate and disseminate effective, low-cost interventions that improve quality of life for veterans, particularly rural veterans, managing complex chronic conditions.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Behavioral: automated internet-mediated walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of an Automated Walking Program Targeting Veterans With COPD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Self-Reported Respiratory-Specific Quality of Life [ Time Frame: assessments taken at four months and twelve months from randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self Reported Dyspnea [ Time Frame: four months and twelve months from enrollment ] [ Designated as safety issue: No ]
  • Days of Hospitalization [ Time Frame: assessed at twelve months from enrollment ] [ Designated as safety issue: No ]
  • Increase in Average Daily Step Counts [ Time Frame: during the final month of the intervention ] [ Designated as safety issue: No ]
  • Goal Commitment, Intervention Reach, Participant Retention, Participant Satisfaction & Adverse Events Rates [ Time Frame: four months and twelve months from enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
participants in the intervention arm are asked to participate in a walking program
Behavioral: automated internet-mediated walking program
intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress

Detailed Description:

Background:

Individuals with COPD who undergo a facility-based, exercise-focused pulmonary rehabilitation program experience significant improvements in health related quality of life, dyspnea, and exercise tolerance as well as reduced rates of hospitalization. Unfortunately, only a small percent of individuals with COPD who could benefit from pulmonary rehabilitation have access to and participate in such programs. Rural veterans are less likely to have access to facility-based pulmonary rehabilitation than urban veterans. Health related quality of life in rural veterans with COPD is significantly worse than for veterans with COPD who live in urban areas. An internet-mediated self-management program for veterans with COPD that focuses on walking could be disseminated widely at low marginal cost to any veteran with COPD who has internet access.

Objectives:

The proposed research is designed to test the effectiveness of an automated internet-mediated walking program for veterans with COPD on improving health related quality of life and reducing days of hospitalization. Additionally, the proposed research will compare measures of intervention reach, participation and satisfaction between urban and rural veterans.

Methods:

This study will recruit approximately 300 participants nationwide by mail and randomly selected from VA medical databases to balance patients from rural and urban zip codes. Participants will be adult VA patients diagnosed with COPD who are also sedentary, ambulatory, have a physician to provide medical clearance, and who have access to a PC computer with an internet connection for e-mail. Interested participants will be directed to a secure VA website where they provide a waiver of signed informed consent and complete a baseline survey. Research staff will obtain medical clearance for walking from patients' designated providers. Participants will then be mailed a pedometer and information to enroll the Stepping Up to Health internet-mediated walking program. At 4 and 12 months, participants will complete a questionnaire measuring patient satisfaction, perceived benefits with the walking website, and the occurrence of any walking related adverse events.

The study is a two-arm randomized controlled trial of an automated internet-mediated walking program targeting veterans with COPD. The two arms are 1) SUH for COPD and 2) wait list control. All study procedures will be delivered remotely including recruitment, consent, medical clearance, intervention delivery and outcome assessment. Equal numbers of urban and rural veterans will be invited, allowing comparisons of intervention reach, participation and satisfaction between urban and rural veterans

Status:

Recruitment began December 2011, and is expected to continue through the fall of 2012. To date we have consented 292 patients and randomized 151.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult >= 40 years old
  • Diagnosis of COPD, emphysema or chronic bronchitis
  • Able to walk a minimum of one block
  • Sedentary, defined by less than 150 minutes of self-reported physical activity per week
  • Have a doctor or primary care provider in the VA who can provide medical clearance
  • Competent to give informed consent
  • Must be a regular email user (check weekly)
  • Have access to a computer with an internet connection, a USB port, and Windows XP or Vista

Exclusion Criteria:

  • Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or procedures within the previous year will be excluded from potential participant pool
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102777

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Caroline R Richardson, MD VA Ann Arbor Healthcare System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01102777     History of Changes
Other Study ID Numbers: IIR 09-366
Study First Received: April 9, 2010
Last Updated: May 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
internet
walking

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013