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

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

Interventions

OTHER

Hybrid care arm

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).

OTHER

Standard of care arm

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).

Sponsors & Collaborators

• patientMpower Ltd.

  collaborator INDUSTRY

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• University College, London

  collaborator OTHER

• New Start, The Wythenshawe Hospital Transplant Fund Centre

  collaborator UNKNOWN

• University of Manchester

  lead OTHER

Principal Investigators

• John Blaikley · The University of Manchester

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-29

Primary Completion

2025-02-27

Completion

2025-02-27

Countries

• United Kingdom

Study Locations