Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)

COPD Exacerbation Clinical Trial

Official title:

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865329
• Other study ID #: 18-002453 (Pilot Study/R61)
• Secondary ID: R61HL142933
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: July 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause.

Description:

Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective.

In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation.

10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria

• COPD related hospitalization and eligible for PR

• Age 40+

• Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

Exclusion Criteria

• Inability to walk (orthopedic-neurologic problems or confined to bed)

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to One Balance Practice Routine	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	Baseline to 3 months
Primary	Adherence to Two Balance Practice Routine	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	Baseline to 3 months
Primary	Adherence to Daily Flexible Practice Routine	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	Baseline to 3 months
Primary	Completion of the Daily Self-assessment	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	Baseline to 3 months
Secondary	Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary	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.	Baseline, 3 months
Secondary	Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary	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.	Baseline, 3 months
Secondary	Daily Physical Activity	Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months	3 months
Secondary	Change in the Self-Management Ability Scale (SMAS) Total Score	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.	Baseline, 3 months
Secondary	Change in Patient Health Questionnaire (PHQ-2)	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.	Baseline, 3 months

External Links

•   Mayo Clinic Clinical Trials