Trial Outcomes & Findings for Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study) (NCT NCT03865329)

Results Overview

Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2020-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention- Home Pulmonary Rehabilitation Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Age, Continuous	68.8 years STANDARD_DEVIATION 5.3 • n=9 Participants
Sex: Female, Male Female	1 Participants n=9 Participants
Sex: Female, Male Male	8 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Adherence to One Balance Practice Routine	49 percentage of participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Adherence to Two Balance Practice Routine	42 percentage of participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Adherence to Daily Flexible Practice Routine	54 percentage of participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Completion of the Daily Self-assessment	61 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 3 months

The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Physical Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best.

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary	0.5 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline, 3 months

The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary	0.6 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 3 months

Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Daily Physical Activity	4086.3 steps Standard Deviation 2552.2

SECONDARY outcome

Timeframe: Baseline, 3 months

Measured using the total score from the self-reported SMAS 30 item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. The SMAS30 has six areas, each with 5 questions. The minimum score is one and the max is 5. The mean is calculated for each section. A higher score indicates better self management.

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Change in the Self-Management Ability Scale (SMAS) Total Score	3.8 score on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: Baseline, 3 months

Measured using the self-reported PHQ-2 consisting of a 2 item questionnaire inquiring about the frequency of depressed mood over the past 2 weeks on a scale of 0 to 3, 0=Not at all, 1=several days, 2=more than half the days, 3=nearly everyday. The minimum score is zero and the highest score is 6. A score greater than 3 may indicate depression.

Outcome measures

Outcome measures
Measure	Intervention- Home Pulmonary Rehabilitation n=9 Participants Participants will be offered a Home-based pulmonary rehabilitation program with health coaching. Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Change in Patient Health Questionnaire (PHQ-2)	-0.6 score on a scale Standard Deviation 1.9

Adverse Events

Intervention- Home Pulmonary Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roberto Benzo

Mayo Clinic

Phone: (507) 284-0561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place