Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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
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
Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Respiratory-Specific Quality of Life | four months from randomization | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Daily Step Counts | baseline 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 Dyspnea | four months from randomization | 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.) |
| Goal Commitment for Intervention Participants | change from four months and twelve months from enrollment | 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. |
| Days of Hospitalization | during study participation, up to 12 months | Number of days of all-cause hospitalization during study participation. |
| Participant Retention | during study participation, up to twelve months | 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. |
| Change in Participant Satisfaction | four to twelve months of study participation | 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. |
| Study Reach Among Rural Participants | At baseline | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 239 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 6 |
| Overall Study | Lost to Follow-up | 7 | 10 |
Baseline characteristics
| Characteristic | Usual Care | Internet-mediated Walking Program | Total |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 9.2 | 66.9 years STANDARD_DEVIATION 8.7 | 66.7 years STANDARD_DEVIATION 8.8 |
| Baseline daily step count; mean | 3521 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 participants | 109 participants | 166 participants |
| Modified Medical Research Council (MMRC) Dyspnea score MMRS Dyspnea Score 2-4 | 27 participants | 46 participants | 73 participants |
| Race/Ethnicity, Customized Black | 3 participants | 7 participants | 10 participants |
| Race/Ethnicity, Customized Other/combined | 2 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized White | 79 participants | 143 participants | 222 participants |
| Region of Enrollment United States | 84 participants | 155 participants | 239 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 77 Participants | 147 Participants | 224 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 84 | 90 / 155 |
| serious Total, serious adverse events | 19 / 84 | 44 / 155 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Self-Reported Respiratory-Specific Quality of Life | -0.8 units on a scale | Standard Deviation 10.9 |
| Internet-mediated Walking Program | Self-Reported Respiratory-Specific Quality of Life | -3.2 units on a scale | Standard Deviation 11.1 |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Self-Reported Respiratory-Specific Quality of Life | -1.4 units on a scale |
| Internet-mediated Walking Program | Self-Reported Respiratory-Specific Quality of Life | -2.5 units on a scale |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Change in Average Daily Step Counts | 163 steps |
| Internet-mediated Walking Program | Change in Average Daily Step Counts | 270 steps |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Internet-mediated Walking Program | Change in Participant Satisfaction | -.14 units on a scale |
Days of Hospitalization
Number of days of all-cause hospitalization during study participation.
Time frame: during study participation, up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Days of Hospitalization | 86 days |
| Internet-mediated Walking Program | Days of Hospitalization | 286 days |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Internet-mediated Walking Program | Goal Commitment for Intervention Participants | -.08 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Participant Retention | 308.8 day |
| Internet-mediated Walking Program | Participant Retention | 329.6 day |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Self Reported Dyspnea | .013 units on a scale | Standard Deviation 0.88 |
| Internet-mediated Walking Program | Self Reported Dyspnea | .029 units on a scale | Standard Deviation 0.94 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Self Reported Dyspnea | -.037 units on a scale | Standard Deviation 0.8 |
| Internet-mediated Walking Program | Self Reported Dyspnea | .035 units on a scale | Standard Deviation 0.86 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Study Reach Among Rural Participants | 2.5 percentage of possible eligible rural |
| Internet-mediated Walking Program | Study Reach Among Rural Participants | 2.5 percentage of possible eligible rural |