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Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)
NA trial testing Intervention- Home-based Pulmonary Rehabilitation in COPD Exacerbation in 9 participants. Completed in 2 August 2019.
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 20 January 2018 |
| Primary completion | 2 August 2019 |
| Estimated completion | 2 August 2019 |
| Sites | 1 location across United States |
Mayo Clinic
40 and older, any sex, with COPD Exacerbation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 49 |
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
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 42 |
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
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 54 |
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
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 61 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 0.5 | ± 1.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 0.6 | ± 1.7 |
Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 4086.3 | ± 2552.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 3.8 | ± 13 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | -0.6 | ± 1.9 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03865329.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing