A comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: A randomised non-inferiority trial

Elizabeth Horton, K.E. Mitchell, Vicki Johnson-Warrington, Lindsay D. Apps, Louise Sewell, M. Morgan, Rod S. Taylor, Sally Singh

Abstract

Background Standardised home-based pulmonary rehabilitation (PR) programmes offer an alternative model to centre-based supervised PR for which uptake is currently poor. We determined if a structured home-based unsupervised PR programme was non-inferior to supervised centre-based PR for participants with COPD.

Methods A total of 287 participants with COPD who were referred to PR (187 male, mean (SD) age 68 (8.86) years, FEV1% predicted 48.34 (17.92)) were recruited. They were randomised to either centre-based PR or a structured unsupervised home-based PR programme including a hospital visit with a healthcare professional trained in motivational interviewing, a self-management manual and two telephone calls. Fifty-eight (20%) withdrew from the centre-based group and 51 (18%) from the home group. The primary outcome was dyspnoea domain in the chronic respiratory disease questionnaire (Chronic Respiratory Questionnaire Self-Report; CRQ-SR) at 7 weeks. Measures were taken blinded. We undertook a modified intention-to-treat (mITT) complete case analysis, comparing groups according to original random allocation and with complete data at follow-up. The non-inferiority margin was 0.5 units.

Results There was evidence of significant gains in CRQ-dyspnoea at 7 weeks in both home and centre-based groups. There was inconclusive evidence that home-based PR was non-inferior to PR in dyspnoea (mean group difference, mITT: −0.24, 95% CI −0.61 to 0.12, p=0.18), favouring the centre group at 7 weeks.

Conclusions The standardised home-based programme provides benefits in dyspnoea. Further evidence is needed to definitively determine if the health benefits of the standardised home-based programme are non-inferior or equivalent to supervised centre-based rehabilitation.

Trial registration number ISRCTN81189044
Original languageEnglish
Pages (from-to)(in press)
JournalThorax
Volume(in press)
DOIs
StatePublished - 29 Jul 2017

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Rehabilitation
Lung
Dyspnea
Chronic Obstructive Pulmonary Disease
Motivational Interviewing
Group Homes
Rehabilitation Centers
Insurance Benefits
Self Care
Random Allocation
Telephone
Self Report
Chronic Disease
Delivery of Health Care

Cite this

Horton, E., Mitchell, K. E., Johnson-Warrington, V., Apps, L. D., Sewell, L., Morgan, M., ... Singh, S. (2017). A comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: A randomised non-inferiority trial. Thorax, (in press), (in press). DOI: 10.1136/thoraxjnl-2016-208506

A comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation : A randomised non-inferiority trial. / Horton, Elizabeth; Mitchell, K.E.; Johnson-Warrington, Vicki; Apps, Lindsay D.; Sewell, Louise; Morgan, M.; Taylor, Rod S.; Singh, Sally.

In: Thorax, Vol. (in press), 29.07.2017, p. (in press).

Research output: Contribution to journalArticle

Horton, E, Mitchell, KE, Johnson-Warrington, V, Apps, LD, Sewell, L, Morgan, M, Taylor, RS & Singh, S 2017, 'A comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: A randomised non-inferiority trial' Thorax, vol (in press), pp. (in press). DOI: 10.1136/thoraxjnl-2016-208506
Horton E, Mitchell KE, Johnson-Warrington V, Apps LD, Sewell L, Morgan M et al. A comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: A randomised non-inferiority trial. Thorax. 2017 Jul 29;(in press):(in press). Available from, DOI: 10.1136/thoraxjnl-2016-208506

Horton, Elizabeth; Mitchell, K.E.; Johnson-Warrington, Vicki; Apps, Lindsay D.; Sewell, Louise; Morgan, M.; Taylor, Rod S.; Singh, Sally / A comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation : A randomised non-inferiority trial.

In: Thorax, Vol. (in press), 29.07.2017, p. (in press).

Research output: Contribution to journalArticle

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abstract = "Background Standardised home-based pulmonary rehabilitation (PR) programmes offer an alternative model to centre-based supervised PR for which uptake is currently poor. We determined if a structured home-based unsupervised PR programme was non-inferior to supervised centre-based PR for participants with COPD.Methods A total of 287 participants with COPD who were referred to PR (187 male, mean (SD) age 68 (8.86) years, FEV1% predicted 48.34 (17.92)) were recruited. They were randomised to either centre-based PR or a structured unsupervised home-based PR programme including a hospital visit with a healthcare professional trained in motivational interviewing, a self-management manual and two telephone calls. Fifty-eight (20%) withdrew from the centre-based group and 51 (18%) from the home group. The primary outcome was dyspnoea domain in the chronic respiratory disease questionnaire (Chronic Respiratory Questionnaire Self-Report; CRQ-SR) at 7 weeks. Measures were taken blinded. We undertook a modified intention-to-treat (mITT) complete case analysis, comparing groups according to original random allocation and with complete data at follow-up. The non-inferiority margin was 0.5 units.Results There was evidence of significant gains in CRQ-dyspnoea at 7 weeks in both home and centre-based groups. There was inconclusive evidence that home-based PR was non-inferior to PR in dyspnoea (mean group difference, mITT: −0.24, 95% CI −0.61 to 0.12, p=0.18), favouring the centre group at 7 weeks.Conclusions The standardised home-based programme provides benefits in dyspnoea. Further evidence is needed to definitively determine if the health benefits of the standardised home-based programme are non-inferior or equivalent to supervised centre-based rehabilitation.Trial registration number ISRCTN81189044",
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AU - Horton,Elizabeth

AU - Mitchell,K.E.

AU - Johnson-Warrington,Vicki

AU - Apps,Lindsay D.

AU - Sewell,Louise

AU - Morgan,M.

AU - Taylor,Rod S.

AU - Singh,Sally

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N2 - Background Standardised home-based pulmonary rehabilitation (PR) programmes offer an alternative model to centre-based supervised PR for which uptake is currently poor. We determined if a structured home-based unsupervised PR programme was non-inferior to supervised centre-based PR for participants with COPD.Methods A total of 287 participants with COPD who were referred to PR (187 male, mean (SD) age 68 (8.86) years, FEV1% predicted 48.34 (17.92)) were recruited. They were randomised to either centre-based PR or a structured unsupervised home-based PR programme including a hospital visit with a healthcare professional trained in motivational interviewing, a self-management manual and two telephone calls. Fifty-eight (20%) withdrew from the centre-based group and 51 (18%) from the home group. The primary outcome was dyspnoea domain in the chronic respiratory disease questionnaire (Chronic Respiratory Questionnaire Self-Report; CRQ-SR) at 7 weeks. Measures were taken blinded. We undertook a modified intention-to-treat (mITT) complete case analysis, comparing groups according to original random allocation and with complete data at follow-up. The non-inferiority margin was 0.5 units.Results There was evidence of significant gains in CRQ-dyspnoea at 7 weeks in both home and centre-based groups. There was inconclusive evidence that home-based PR was non-inferior to PR in dyspnoea (mean group difference, mITT: −0.24, 95% CI −0.61 to 0.12, p=0.18), favouring the centre group at 7 weeks.Conclusions The standardised home-based programme provides benefits in dyspnoea. Further evidence is needed to definitively determine if the health benefits of the standardised home-based programme are non-inferior or equivalent to supervised centre-based rehabilitation.Trial registration number ISRCTN81189044

AB - Background Standardised home-based pulmonary rehabilitation (PR) programmes offer an alternative model to centre-based supervised PR for which uptake is currently poor. We determined if a structured home-based unsupervised PR programme was non-inferior to supervised centre-based PR for participants with COPD.Methods A total of 287 participants with COPD who were referred to PR (187 male, mean (SD) age 68 (8.86) years, FEV1% predicted 48.34 (17.92)) were recruited. They were randomised to either centre-based PR or a structured unsupervised home-based PR programme including a hospital visit with a healthcare professional trained in motivational interviewing, a self-management manual and two telephone calls. Fifty-eight (20%) withdrew from the centre-based group and 51 (18%) from the home group. The primary outcome was dyspnoea domain in the chronic respiratory disease questionnaire (Chronic Respiratory Questionnaire Self-Report; CRQ-SR) at 7 weeks. Measures were taken blinded. We undertook a modified intention-to-treat (mITT) complete case analysis, comparing groups according to original random allocation and with complete data at follow-up. The non-inferiority margin was 0.5 units.Results There was evidence of significant gains in CRQ-dyspnoea at 7 weeks in both home and centre-based groups. There was inconclusive evidence that home-based PR was non-inferior to PR in dyspnoea (mean group difference, mITT: −0.24, 95% CI −0.61 to 0.12, p=0.18), favouring the centre group at 7 weeks.Conclusions The standardised home-based programme provides benefits in dyspnoea. Further evidence is needed to definitively determine if the health benefits of the standardised home-based programme are non-inferior or equivalent to supervised centre-based rehabilitation.Trial registration number ISRCTN81189044

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DO - 10.1136/thoraxjnl-2016-208506

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JO - Thorax

JF - Thorax

SN - 0040-6376

SN - 1468-3296

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