Hybrid Pulmonary Rehabilitation Study

NCT05881590 | Completed

• 1 other identifier: HEMS_2223001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary rehabilitation is an exercise and education programme that helps improve breathlessness and quality of life for people living with lung and breathing problems. It improves exercise levels and breathlessness and is a recommended treatment for people with lung diseases and symptoms. Standard pulmonary rehabilitation programmes involve individuals attending group classes at hospitals or community centres, twice a week for 8 weeks. These classes are supervised by physiotherapists. At the moment, there are long waiting times for pulmonary rehabilitation in the NHS. Some patients may prefer more pulmonary rehabilitation based in their own home. This might be because they find it difficult to travel to classes. Some would like to do more home pulmonary rehabilitation in between supervised classes or continue pulmonary rehabilitation after the 8-week supervised programme. The blending between supervised classes and home pulmonary rehabilitation is known as HYBRID PULMONARY REHABILITATION. Hybrid pulmonary rehabilitation is not being provided routinely in the NHS, but the NHS would like to see it used more as it might help reduce waiting times and give patients more choice on how to access pulmonary rehabilitation. The study will assess the feasibility of a larger study to provide strong evidence on patients' uptake and adherence to the hybrid programme, and the impact on patients' health outcomes and service delivery. The investigators will also look at what measures would be best to use in a larger study. The study will recruit up to 100 patients. These individuals will be aged 18 years or older, have respiratory disease and a referral for pulmonary rehabilitation. Individuals with reasons why they cannot exercise will be excluded. Participants will be provided with an application (App) that can be installed on a mobile phone. This App is called Active+me REMOTE and is made by a company called Aseptika Ltd (www.activ8rlives.com). Active+me REMOTE provides live online, video exercise classes; pre-recorded exercise classes; a walking programme; educational talks; and a care plan personalised for the user. Data will be collected at the beginning and end of the hybrid pulmonary rehabilitation programme and will include routinely collected data as part of usual care. Additional data will be collected via the App and trial surveys. The investigators will ask staff and patients about the experiences of the new way of delivering rehabilitation and explore how cost effective it is.

Conditions

Respiratory Disease

Keywords

Pulmonary Rehabilitation; hybrid delivery; real-word design; quantitative and qualitative research; health economic analysis

Outcome Measures

Primary Outcomes (8)

• Feasibility - patient recruitment rates

  Number of patients recruited within the anticipated recruitment timeframe of the study

  4 months (recruitment rate: 6 patients per week)

• Feasibility - recruitment

  Frequency of reasons for non-participation

  4 months

• Feasibility - participant retention rates

  The percentage of participants who do not withdraw from the study once consented

  6 months [from recruitment start to end of data collection]

• Feasibility - Availability of data for primary and secondary outcomes of a larger definitive trial

  The percentage of missing data extracted from routine records and trial surveys

  At the end of the 8-week intervention

• Feasibility - success of propensity matching of control group

  Similarities in the baseline characteristics of intervention arm and retrospective control group including: age (years); sex (M/F); measure of respiratory disability (Grade 0-4), socioeconomic status (index of multiple deprivation); exercise capacity (incremental shuffle walk test); and hospital vs community setting.

  Baseline

• Feasibility - Success of integrating hybrid pulmonary rehabilitation into routine practice

  Qualitative feedback via focus groups from pulmonary rehabilitation staff teams

  5-6 months

• Feasibility - patient/staff acceptability of the hybrid pulmonary rehabilitation programme

  Qualitative feedback via interviews/focus groups from patients/pulmonary rehabilitation staff teams

  5-6 months

• Feasibility - safety of the hybrid pulmonary rehabilitation programme

  Number of adverse events recorded in participants

  6 months [from recruitment start to end of data collection]

Secondary Outcomes (22)

• Patient uptake of the hybrid pulmonary rehabilitation programme

  At the end of the 8-week intervention

• Pulmonary rehabilitation class sessions completed

  At the end of the 8-week intervention/programme

• Drop out rate from pulmonary rehabilitation

  At the end of the 8-week intervention/programme

• Changes in exercise capacity measures

  Change from baseline until the end of the 8-week intervention/programme

• Adherence to the hybrid pulmonary rehabilitation programme (activity adherence)

  At the end of the 8-week intervention

Study Arms (1)

Hybrid pulmonary rehabilitation

EXPERIMENTAL

Other: Hybrid pulmonary rehabilitation

Interventions

Hybrid pulmonary rehabilitation OTHER

Technology-enabled 8-week pulmonary rehabilitation programme using the Active+me REMOTE App

Hybrid pulmonary rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are aged 18 years or older
• Have a grade of 2 - 5 on the MRC Dyspnoea Scale and are referred for pulmonary rehabilitation
• Are willing and have capacity to consent to take part in the trial

You may not qualify if:

• \- contraindications to exercise (e.g. unstable cardiac disease)

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Aseptika Ltd.: collaborator
• So What? Consultancy Ltd.: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust - Harefield Hospital

Harefield, Uxbridge, UB9 6JH, United Kingdom

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Graham Ball, PhD, BSc

  Anglia Ruskin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Real-world study design drawing largely on routinely collected data to compare outcomes for patients recruited to a hybrid pulmonary rehabilitation programme with a propensity matched control group that has previously received standard pulmonary rehabilitation as part of usual care.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 31, 2023
• Study Start: May 4, 2023
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: July 17, 2024

Record last verified: 2023-05

Locations

GB (1)