Trial Outcomes & Findings for Stepping up to Health - for Veterans With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01102777)

NCT ID: NCT01102777

Last Updated: 2016-06-07

Results Overview

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.)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 307 participants
• Primary outcome timeframe: four months from randomization
• Results posted on: 2016-06-07

Participant Flow

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

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).

Participant milestones

Measure	Usual Care Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	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
Overall Study STARTED	84	155
Overall Study COMPLETED	75	139
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Measure	Usual Care Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	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
Overall Study Death	2	6
Overall Study Lost to Follow-up	7	10

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Usual Care n=84 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	Internet-mediated Walking Program n=155 Participants 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	Total n=239 Participants Total of all reporting groups
Age, Continuous	66.4 years STANDARD_DEVIATION 9.2 • n=5 Participants	66.9 years STANDARD_DEVIATION 8.7 • n=7 Participants	66.7 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	147 Participants n=7 Participants	224 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized White	79 participants n=5 Participants	143 participants n=7 Participants	222 participants n=5 Participants
Race/Ethnicity, Customized Other/combined	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	84 participants n=5 Participants	155 participants n=7 Participants	239 participants n=5 Participants
St George's Respiratory Questionnaire (SGRQ)	46.8 units on a scale STANDARD_DEVIATION 15.6 • n=5 Participants	45.5 units on a scale STANDARD_DEVIATION 15.4 • n=7 Participants	46.0 units on a scale STANDARD_DEVIATION 15.4 • n=5 Participants
Modified Medical Research Council (MMRC) Dyspnea score MMRS Dyspnea Score 0-1	57 participants n=5 Participants	109 participants n=7 Participants	166 participants n=5 Participants
Modified Medical Research Council (MMRC) Dyspnea score MMRS Dyspnea Score 2-4	27 participants n=5 Participants	46 participants n=7 Participants	73 participants n=5 Participants
Baseline daily step count; mean	3521 steps STANDARD_DEVIATION 2058 • n=5 Participants	3484 steps STANDARD_DEVIATION 2309 • n=7 Participants	3497 steps STANDARD_DEVIATION 2220 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.)

Outcome measures

Measure	Internet-mediated Walking Program n=144 Participants 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	Usual Care n=77 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Self-Reported Respiratory-Specific Quality of Life	-3.2 units on a scale Standard Deviation 11.1	-0.8 units on a scale Standard Deviation 10.9

PRIMARY outcome

Timeframe: twelve months from randomization

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

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.)

Outcome measures

Measure	Internet-mediated Walking Program n=154 Participants 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	Usual Care n=84 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Self-Reported Respiratory-Specific Quality of Life	-2.5 units on a scale Interval -4.5 to -0.6	-1.4 units on a scale Interval -4.1 to 1.3

SECONDARY outcome

Timeframe: 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.

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.")

Outcome measures

Measure	Internet-mediated Walking Program n=144 Participants 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	Usual Care n=81 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Self Reported Dyspnea	.035 units on a scale Standard Deviation .86	-.037 units on a scale Standard Deviation .8

SECONDARY outcome

Timeframe: 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.

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.")

Outcome measures

Measure	Internet-mediated Walking Program n=137 Participants 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	Usual Care n=75 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Self Reported Dyspnea	.029 units on a scale Standard Deviation .94	.013 units on a scale Standard Deviation .88

SECONDARY outcome

Timeframe: during study participation, up to 12 months

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

Outcome measures

Measure	Internet-mediated Walking Program n=155 Participants 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	Usual Care n=84 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Days of Hospitalization	286 days	86 days

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Internet-mediated Walking Program n=154 Participants 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	Usual Care n=84 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Change in Average Daily Step Counts	270 steps Interval -86.0 to 626.0	163 steps Interval -336.0 to 661.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Internet-mediated Walking Program n=146 Participants 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	Usual Care Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Goal Commitment for Intervention Participants	-.08 units on a scale Interval -0.32 to 0.16	—

SECONDARY outcome

Timeframe: At baseline

Population: number of 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.

Outcome measures

Measure	Internet-mediated Walking Program n=71 Participants 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	Usual Care n=37 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Study Reach Among Rural Participants	2.5 percentage of possible eligible rural	2.5 percentage of possible eligible rural

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Internet-mediated Walking Program n=154 Participants 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	Usual Care n=84 Participants Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Participant Retention	329.6 day Interval 314.2 to 345.0	308.8 day Interval 287.9 to 329.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Internet-mediated Walking Program n=146 Participants 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	Usual Care Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
Change in Participant Satisfaction	-.14 units on a scale Interval -0.26 to -0.03	—

Adverse Events

Usual Care

Serious events: 19 serious events

Other events: 39 other events

Deaths: 0 deaths

Internet-mediated Walking Program

Serious events: 44 serious events

Other events: 90 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=84 participants at risk Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	Internet-mediated Walking Program n=155 participants at risk 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
General disorders General disorders	22.6% 19/84 • Number of events 28 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record	28.4% 44/155 • Number of events 64 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record

Other adverse events

Measure	Usual Care n=84 participants at risk Control group, instructed to wear the pedometer but not provided with walking goals or instruction.	Internet-mediated Walking Program n=155 participants at risk 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
Musculoskeletal and connective tissue disorders Musculoskeletal	9.5% 8/84 • Number of events 9 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record	27.7% 43/155 • Number of events 70 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record
Cardiac disorders Cardiac disorders	1.2% 1/84 • Number of events 1 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record	1.9% 3/155 • Number of events 3 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record
Respiratory, thoracic and mediastinal disorders Pulmonary	32.1% 27/84 • Number of events 35 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record	25.2% 39/155 • Number of events 156 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record
General disorders Other	3.6% 3/84 • Number of events 3 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record	3.2% 5/155 • Number of events 6 • During study participation, up to twelve months. Participants could report adverse events at any time. Participants in both groups were also prompted monthly to report new or worsening medical symptoms or problems, whether or not study related. Additionally, data for hospitalizations was gathered from VA medical record

Additional Information

Fatima Makki

VA Ann Arbor Center for Clinical Management Research

Phone: +1 (734) 845-3623

Email: Fatima.Makki@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place