ISRCTN12658458已完成未知
Improving life quality in chronic obstructive pulmonary disease (COPD) by increasing uptake and completion of pulmonary rehabilitation with lay health workers: a cluster randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1,577
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38500191/ (added 22/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Category A - Inclusion criteria of participating pulmonary rehabilitation sites:
- •1. > 200 pulmonary rehabilitation referrals per year to allow for at least 35 (17.5%) participants to be recruited over six months.
- •2. Conduct routine baseline and final pulmonary rehabilitation session data including uptake and completion rates, quality of life assessment (COPD Assessment Test-CAT or Chronic Respiratory Questionnaire -CRQ-SAS), exercise tests (Six Minute Walking Distance - 6MWD or Intermittent Shuttle Walk Test - ISWT), and well-being assessment (General Anxiety Disorder Assessment 7 – GAD7) and (Patient Health Questionnaire 9 -PHQ9 or Hospital Anxiety and Depression Scale HADS).
- •3. Completion rate < = 55% determined by count based on appropriate referrals received. Referrals of non-COPD chest problems and patients with significant other disabilities that prevent participation should not be included in the completion rate denominator. The decision to limit inclusion to sites with a completion rate of 55% or less relates to the priority given to service inequalities and the need for the NHS to have a threshold for the introduction of the intervention. Including all sites may diminish the opportunity to show a difference in those services in greatest need.
- •4. Agree to randomisation to intervention or usual care
- •5. Agree to include all eligible patients in the invitation to be randomised for the PRB intervention or usual care.
- •6. Agree to release three pulmonary rehabilitation staff for training (not simultaneously) over 2 days with an additional half-day remote training
- •7. Agree that two pulmonary rehabilitation staff will undertake intervention delivery
- •8. Agree on the third pulmonary rehabilitation staff member to have a backup role in event of a colleague becoming ill or leaving the service during recruitment and LHW training.
- •9. At least two of three participating staff members to be a registered healthcare professional (HCP)
- •10. If the third member is a non-HCP then should be at least Band 4 NHS pay scale
- •11. All team members to have at least one year’s experience in pulmonary rehabilitation
- •Category B - Inclusion criteria of intervention site participating team members:
- •1. Aged 18 years or over
- •2. Be employed member of staff within the pulmonary rehabilitation service at the intervention site whether NHS or non-NHS service
- •3. Willing to undertake 2½ days of training to train, recruit, manage and support PRBs
- •4. Willing to manage and support PRBs over a nine-month period
- •5. Willing to take part in research activities including keeping accurate records
- •Category C - Inclusion criteria of pulmonary rehabilitation buddy volunteers:
- •1. Aged 18 years or over
- •2. COPD diagnosis and pulmonary rehabilitation completion within the previous year
- •3. Volunteer for the role
- •4. Willing to undertake training and be supervised by the pulmonary rehabilitation team
- •5. Willing to support at least 6 pulmonary rehabilitation patients over 9 months
- •6. Able to travel independently
- •7. Agree to use encrypted smartphones (after training) for recording conversations with supported patients
- •Category D - Inclusion criteria of participating patients:
- •1. Aged 18 years or over.
- •2. COPD diagnosis
- •3. Referred to pulmonary rehabilitation service
- •4. Medical Research Council (MRC) breathlessness score > 2
- •5. Consent to be randomised to intervention or usual care arm of the trial
- •6. Consent to receive telephone contact by PRB and to mee
排除标准
- •Category A - Exclusion criteria of participating pulmonary rehabilitation sites:
- •1. Unable to join trial until after June 2023
- •2. Unable to identify at least three members of staff for the trial willing to consent to participation
- •3. Local trust R&D office unwilling to support the trial
- •Category B - Exclusion criteria of pulmonary rehabilitation site participating staff:
- •1. Will not be employed in their post for the duration of the trial at the site in question
- •Category C - Exclusion criteria of pulmonary rehabilitation buddy volunteers
- •1. Unable to participate for the duration of the trial at the site in question
- •2. Unable to travel independently to meet referred patients
- •3. Unable or unwilling to use a smart mobile phone
- •4. Unable to give valid consent
- •5. Failed DBS check
- •Category D - Exclusion criteria of participating patients
- •1. Poorly controlled angina on minimal exertion
- •2. Myocardial infarction in 6 weeks prior to commencement of the programme
- •3. Breathlessness as a result of cardiac disease.
- •4. Uncontrolled hypertension
- •5. Any medical problem that severely restricts exercise or compliance with the programme e.g. severe arthritis or dementia
- •6. Unable to give valid consent
- •7. Unable to join until after month 20 of the trial
研究者
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