N/A
Completed N=239
Stepping up to Health - for Veterans With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01102777 ↗Enrolled (actual)
239
Serious AEs
26.4%
Results posted
Jun 2016
Primary outcomePrimary: Self-Reported Respiratory-Specific Quality of Life — -0.8; -3.2 units on a scale — p=0.142
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported Respiratory-Specific Quality of Life |
-1.4; -2.5 | .502 |
| SECONDARY Self Reported Dyspnea |
.013; .029 | .93 |
| SECONDARY Days of Hospitalization |
86; 286 | .08 |
| SECONDARY Change in Average Daily Step Counts |
163; 270 | 0.731 |
| SECONDARY Goal Commitment for Intervention Participants |
-.08 | .52 |
| SECONDARY Study Reach Among Rural Participants |
2.5; 2.5 | — |
| SECONDARY Participant Retention |
308.8; 329.6 | .11 |
| SECONDARY Change in Participant Satisfaction |
-.14 | .01 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01102777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.