An Evaluation of Remote Care (Questionnaire+Hybrid) in Patients Who Are Post-lung Transplant

NCT05916495 | Completed

• 1 other identifier: LTX patientMpower 01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Lung transplantation is used to treat patients with lung damage when there is no other treatment option. Patients require close monitoring following their transplant, with hospital check-ups every 3-4 months usually lasting all day. Although check-ups often result in no change to patient management they are essential as patients have better outcomes if complications are detected quickly. The aim is to explore whether remote monitoring via an app (patientMpower) ± questionnaire (specifically designed to assess post-transplant patients' health), linked to a device to measure lung function, could replace some check-ups for lung transplant patients. Patients will be randomised to receive either normal care or remote monitoring (i.e. their symptoms will be evaluated using home spirometry combined with a questionnaire). 100 lung transplant recipients will be enrolled with 50 patients being assigned to either group. Health outcomes and costs of care between the two groups will be compared

Conditions

Lung Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Number of clinic visits per patient

  The number of clinic follow up visits in the observation period

  6 months

Secondary Outcomes (6)

• Number of unplanned clinic visits per patient

  6 months

• "Measuring the Utilization Rate of Remote Monitoring for Patient Engagement" "Measuring the Utilization Rate of Remote Monitoring for Patient Engagement" Number of patient interactions with the remote monitoring platform

  6 months

• Hospitalisation due to deterioration of allograft function

  6 Months

• Duration of hospitalisations due to deterioration of allograft function

  6 Months

• Number of planned clinic visits per patient

  6 Months

Study Arms (2)

Hybrid care arm

EXPERIMENTAL

Remote review of information collected electronically will be combined with in person visits at a hospital

Other: Hybrid care arm

Standard of care arm

ACTIVE COMPARATOR

Patients will be seen in person at a hospital clinic.

Other: Standard of care arm

Interventions

Hybrid care arm OTHER

Patients will be evaluated at 3 months via a remote review. This will review the patients-recorded spirometry and a questionnaire developed for this study which asses the patients' symptom burden and medication adherence. All patients participating in the study will be offered remote monitoring (patient facing app+ patient recorded home spirometry).

Hybrid care arm

Standard of care arm OTHER

Patients will be reviewed in clinic at 3 months per the standard of care. All patients participating in the study will be offered remote monitoring (patient facing app+ patient recorded home spirometry).

Standard of care arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Looked after by a clinical care team at Manchester University NHS Foundation Trust
• Given consent
• Have received a lung transplant

You may not qualify if:

• Consent not given
• Not able to operate the remote monitoring platform

Sponsors & Collaborators

• University of Manchester: lead
• patientMpower Ltd.: collaborator
• Manchester University NHS Foundation Trust: collaborator
• University College, London: collaborator
• New Start, The Wythenshawe Hospital Transplant Fund Centre: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (1)

• Varley RJ, Borton R, Van Dellen D, Santhanakrishnan K, Edwards C, Pizzo E, Blaikley JF. Description of the Protocol Investigating Whether Remote Care Can Reduce Clinic Attendance in Lung Transplantation. Pulm Ther. 2025 Dec;11(4):765-773. doi: 10.1007/s41030-025-00320-3. Epub 2025 Oct 10.

  PMID: 41073612 DERIVED

Study Officials

• John Blaikley

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: September 29, 2023
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)