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

NCT01102777 | Completed Results

• 1 other identifier: IIR 09-366
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

internet; walking

Outcome Measures

Primary Outcomes (2)

• Self-Reported Respiratory-Specific Quality of Life

  Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.)

  four months from randomization

• Self-Reported Respiratory-Specific Quality of Life

  Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)

  twelve months from randomization

Secondary Outcomes (8)

• Self Reported Dyspnea

  four months from randomization

• Self Reported Dyspnea

  twelve months from randomization

• Days of Hospitalization

  during study participation, up to 12 months

• Change in Average Daily Step Counts

  baseline and final two weeks of the intervention and the two weeks post intervention.

• Goal Commitment for Intervention Participants

  change from four months and twelve months from enrollment

Study Arms (2)

Usual Care

OTHER

Control group, instructed to wear the pedometer but not provided with walking goals or instruction.

Other: Usual Care

Internet-mediated Walking Program

OTHER

participants in the intervention arm are asked to participate in a walking program 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

Behavioral: automated internet-mediated walking program

Interventions

automated internet-mediated walking program BEHAVIORAL

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

Internet-mediated Walking Program

Usual Care OTHER

Control group, instructed to wear the pedometer but not provided with walking goals or instruction.

Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or procedures within the previous year will be excluded from potential participant pool

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113-0170, United States

Location

Related Publications (4)

• Ney JP, Robinson SA, Richardson CR, Moy ML. Can Technology-Based Physical Activity Programs for Chronic Obstructive Pulmonary Disease Be Cost-Effective? Telemed J E Health. 2021 Nov;27(11):1288-1292. doi: 10.1089/tmj.2020.0398. Epub 2021 Feb 24.

  PMID: 33625893 DERIVED

• Moy ML, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, Nguyen HQ, Cohen MD, Goodrich DE, Giardino ND, Richardson CR. Long-Term Effects of an Internet-Mediated Pedometer-Based Walking Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. J Med Internet Res. 2016 Aug 8;18(8):e215. doi: 10.2196/jmir.5622.

  PMID: 27502583 DERIVED

• Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, Nguyen HQ, Cohen MD, Goodrich DE, Giardino ND, Richardson CR. An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Chest. 2015 Jul;148(1):128-137. doi: 10.1378/chest.14-1466.

  PMID: 25811395 DERIVED

• Martinez CH, Moy ML, Nguyen HQ, Cohen M, Kadri R, Roman P, Holleman RG, Kim HM, Goodrich DE, Giardino ND, Richardson CR. Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease. BMC Pulm Med. 2014 Feb 3;14:12. doi: 10.1186/1471-2466-14-12.

  PMID: 24491137 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Fatima Makki
• Organization: VA Ann Arbor Center for Clinical Management Research

Fatima.Makki@va.gov

+1 (734) 845-3623

Study Officials

• Caroline R Richardson, MD

  VA Ann Arbor Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 13, 2010
• Study Start: December 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 7, 2016
• Results First Posted: June 7, 2016

Record last verified: 2016-04

Locations

US (1)