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

Effectiveness of an Automated Walking Program Targeting Veterans With COPD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01102777
Enrollment
307
Registered
2010-04-13
Start date
2011-12-31
Completion date
2014-01-31
Last updated
2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

internet, walking

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.

Detailed description

Background: Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. 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. Moreover, the benefits of short-term pulmonary rehabilitation programs tend to diminish rapidly after the program ends. 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. Objectives: The primary objective of this study was to assess the efficacy of an Internet-mediated, pedometer-based intervention designed to increase walking and health related quality of life for Veterans with COPD. The specific aims of this randomized controlled trial (RCT) with a wait list control were: 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; 2) to estimate the effect of the internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization; and 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm. Methods: Participants were followed for 12 months to investigate the efficacy of the intervention in assisting patients with initiating and maintaining a regular walking program and improving health related quality of life. Eligible and consented patients wore a pedometer to obtain one week of baseline data and then were randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm received iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls were notified that they were enrolled, but that their intervention would start in one year; however, they kept the pedometer and had access to a static webpage. Both groups completed on-line survey assessments at baseline, 4, and 12 months, and were asked to report adverse events on a regular basis. The primary outcome was changes in health related quality of life, as measured using the St George's Respiratory Questionnaire (SGRQ), a disease-specific instrument in patients with COPD. Secondary outcomes included days of hospitalization during the one-year intervention period, changes in average daily steps as measured using the study pedometer, self-reported dyspnea, intervention reach, and adverse event rates. The analysis was conducted based \[on the original randomized treatment assignment regardless of participation (an intent-to-treat analysis) and included both a complete case analysis as well as an all case analysis using a linear mixed-effects model. Between-group differences in change scores (4 months or 12 months) were estimated after adjusting for baseline values of the outcome variables. Status: This study is completed. Data analysis and manuscript preparation continue.

Interventions

BEHAVIORALautomated 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

OTHERUsual Care

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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-Reported Respiratory-Specific Quality of Lifefour months from randomizationChange 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.)

Secondary

MeasureTime frameDescription
Change in Average Daily Step Countsbaseline and final two weeks of the intervention and the two weeks post intervention.Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.
Self Reported Dyspneafour months from randomizationChange in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)
Goal Commitment for Intervention Participantschange from four months and twelve months from enrollmentChange in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as Strongly Disagree and 5 is Strongly Agree to the question, I am strongly committed to pursuing my step count goal. A negative change value indicates lower goal commitment.
Days of Hospitalizationduring study participation, up to 12 monthsNumber of days of all-cause hospitalization during study participation.
Participant Retentionduring study participation, up to twelve monthsThe last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.
Change in Participant Satisfactionfour to twelve months of study participationChange in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is Definitely True 5 is Definitely False to the question, I would recommend the Taking Healthy Steps walking program to another person with COPD. A negative change value indicates higher satisfaction score.
Study Reach Among Rural ParticipantsAt baselineCalculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.

Countries

United States

Participant flow

Recruitment details

Recruitment was conducted entirely through mail, phone, or internet. Recruitment start was December 2011.

Pre-assignment details

Randomization required Medical Clearance, the completed Baseline Survey, and valid baseline pedometer data. While 307 participants were Consented, only 239 were randomized. The top three reasons for not being randomized were: Pt withdrew prior (23) Failed to submit Medical Clearance and pedometer data (19) or failed to submit Baseline survey (9).

Participants by arm

ArmCount
Usual Care
Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
84
Internet-mediated Walking Program
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
155
Total239

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath26
Overall StudyLost to Follow-up710

Baseline characteristics

CharacteristicUsual CareInternet-mediated Walking ProgramTotal
Age, Continuous66.4 years
STANDARD_DEVIATION 9.2
66.9 years
STANDARD_DEVIATION 8.7
66.7 years
STANDARD_DEVIATION 8.8
Baseline daily step count; mean3521 steps
STANDARD_DEVIATION 2058
3484 steps
STANDARD_DEVIATION 2309
3497 steps
STANDARD_DEVIATION 2220
Modified Medical Research Council (MMRC) Dyspnea score
MMRS Dyspnea Score 0-1
57 participants109 participants166 participants
Modified Medical Research Council (MMRC) Dyspnea score
MMRS Dyspnea Score 2-4
27 participants46 participants73 participants
Race/Ethnicity, Customized
Black
3 participants7 participants10 participants
Race/Ethnicity, Customized
Other/combined
2 participants5 participants7 participants
Race/Ethnicity, Customized
White
79 participants143 participants222 participants
Region of Enrollment
United States
84 participants155 participants239 participants
Sex: Female, Male
Female
7 Participants8 Participants15 Participants
Sex: Female, Male
Male
77 Participants147 Participants224 Participants
St George's Respiratory Questionnaire (SGRQ)46.8 units on a scale
STANDARD_DEVIATION 15.6
45.5 units on a scale
STANDARD_DEVIATION 15.4
46.0 units on a scale
STANDARD_DEVIATION 15.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
39 / 8490 / 155
serious
Total, serious adverse events
19 / 8444 / 155

Outcome results

Primary

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.)

Time frame: four months from randomization

Population: One Intervention participant was dropped from analysis due to being an extreme outlier. In addition, not all participants had complete SGRQ data at both time points for analysis.

ArmMeasureValue (MEAN)Dispersion
Usual CareSelf-Reported Respiratory-Specific Quality of Life-0.8 units on a scaleStandard Deviation 10.9
Internet-mediated Walking ProgramSelf-Reported Respiratory-Specific Quality of Life-3.2 units on a scaleStandard Deviation 11.1
p-value: 0.142Regression, Linear
Primary

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.)

Time frame: twelve months from randomization

Population: One Intervention participant was dropped from analysis due to being an extreme outlier.

ArmMeasureValue (MEAN)
Usual CareSelf-Reported Respiratory-Specific Quality of Life-1.4 units on a scale
Internet-mediated Walking ProgramSelf-Reported Respiratory-Specific Quality of Life-2.5 units on a scale
p-value: 0.502Mixed Models Analysis
Secondary

Change in Average Daily Step Counts

Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.

Time frame: baseline and final two weeks of the intervention and the two weeks post intervention.

Population: One Intervention participant was dropped from analysis due to being an extreme outlier.

ArmMeasureValue (MEAN)
Usual CareChange in Average Daily Step Counts163 steps
Internet-mediated Walking ProgramChange in Average Daily Step Counts270 steps
p-value: 0.731Mixed Models Analysis
Secondary

Change in Participant Satisfaction

Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is Definitely True 5 is Definitely False to the question, I would recommend the Taking Healthy Steps walking program to another person with COPD. A negative change value indicates higher satisfaction score.

Time frame: four to twelve months of study participation

Population: This was only assessed on Intervention group participants who answered the question at either four or twelve months.

ArmMeasureValue (MEAN)
Internet-mediated Walking ProgramChange in Participant Satisfaction-.14 units on a scale
p-value: 0.01Mixed Models Analysis
Secondary

Days of Hospitalization

Number of days of all-cause hospitalization during study participation.

Time frame: during study participation, up to 12 months

ArmMeasureValue (NUMBER)
Usual CareDays of Hospitalization86 days
Internet-mediated Walking ProgramDays of Hospitalization286 days
p-value: 0.08Zero inflated Poisson regression
Secondary

Goal Commitment for Intervention Participants

Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as Strongly Disagree and 5 is Strongly Agree to the question, I am strongly committed to pursuing my step count goal. A negative change value indicates lower goal commitment.

Time frame: change from four months and twelve months from enrollment

Population: This measure was only assessed on the Intervention group, and only 146 participants answered the question at either time points.

ArmMeasureValue (MEAN)
Internet-mediated Walking ProgramGoal Commitment for Intervention Participants-.08 units on a scale
p-value: 0.52Mixed Models Analysis
Secondary

Participant Retention

The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.

Time frame: during study participation, up to twelve months

ArmMeasureValue (MEAN)
Usual CareParticipant Retention308.8 day
Internet-mediated Walking ProgramParticipant Retention329.6 day
p-value: 0.11Regression, Linear
Secondary

Self Reported Dyspnea

Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)

Time frame: twelve months from randomization

Population: One Intervention participant was dropped from analysis due to being an extreme outlier. Nine Control and seventeen Intervention participants were missing data at 12 months.

ArmMeasureValue (MEAN)Dispersion
Usual CareSelf Reported Dyspnea.013 units on a scaleStandard Deviation 0.88
Internet-mediated Walking ProgramSelf Reported Dyspnea.029 units on a scaleStandard Deviation 0.94
p-value: 0.93Regression, Linear
Secondary

Self Reported Dyspnea

Change in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)

Time frame: four months from randomization

Population: One Intervention participant was dropped from analysis due to being an extreme outlier. Three Control and ten Intervention were missing values at 4 months.

ArmMeasureValue (MEAN)Dispersion
Usual CareSelf Reported Dyspnea-.037 units on a scaleStandard Deviation 0.8
Internet-mediated Walking ProgramSelf Reported Dyspnea.035 units on a scaleStandard Deviation 0.86
p-value: 0.9Regression, Linear
Secondary

Study Reach Among Rural Participants

Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.

Time frame: At baseline

Population: number of rural participants.

ArmMeasureValue (NUMBER)
Usual CareStudy Reach Among Rural Participants2.5 percentage of possible eligible rural
Internet-mediated Walking ProgramStudy Reach Among Rural Participants2.5 percentage of possible eligible rural
Comparison: The determination of arm occurred after recruitment, and Study Reach is a recruitment value.

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026