Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)
24. juli 2020 opdateret af: Roberto P. Benzo, Mayo Clinic
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
9
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention- Home Pulmonary Rehabilitation
Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.
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Hjemmebaseret lungerehabilitering (PR) med sundhedscoaching ved hjælp af et fjernsystem, der giver patienterne mulighed for at gennemføre PR derhjemme.
Programmet involverer over- og underekstremitetsøvelser, selvrapportering af symptomer (træthed, åndenød, fysisk aktivitet og generelt velvære).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence to One Balance Practice Routine
Tidsramme: 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
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Baseline to 3 months
|
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Adherence to Two Balance Practice Routine
Tidsramme: 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
|
Baseline to 3 months
|
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Adherence to Daily Flexible Practice Routine
Tidsramme: 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
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Baseline to 3 months
|
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Completion of the Daily Self-assessment
Tidsramme: 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
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Baseline to 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary
Tidsramme: 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.
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Baseline, 3 months
|
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Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary
Tidsramme: Baseline, 3 months
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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.
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Baseline, 3 months
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Daily Physical Activity
Tidsramme: 3 months
|
Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months
|
3 months
|
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Change in the Self-Management Ability Scale (SMAS) Total Score
Tidsramme: Baseline, 3 months
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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.
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Baseline, 3 months
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Change in Patient Health Questionnaire (PHQ-2)
Tidsramme: Baseline, 3 months
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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.
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Baseline, 3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Roberto P Benzo, MD, Mayo Clinic
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. januar 2018
Primær færdiggørelse (Faktiske)
2. august 2019
Studieafslutning (Faktiske)
2. august 2019
Datoer for studieregistrering
Først indsendt
21. januar 2019
Først indsendt, der opfyldte QC-kriterier
5. marts 2019
Først opslået (Faktiske)
6. marts 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 18-002453 (Pilot Study/R61)
- R61HL142933 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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