Lung Transplant; ComplicationsNCT05916495
An Evaluation of Remote Care (Questionnaire+Hybrid) in Patients Who Are Post-lung Transplant
A study testing Hybrid care arm in people with Lung Transplant; Complications, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Hybrid care arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2023to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Looked after by a clinical care team at Manchester University NHS Foundation Trust
- Given consent
- Have received a lung transplant
Who cannot join
- Consent not given
- Not able to operate the remote monitoring platform
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester
About this study
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
Read the detailed description
100 lung transplant patients are expected to be recruited. Consent will be taken by the research team. Following admission they will be randomised to the interventional or control arms. The control arm will consist of follow-up according to unit policy, in the majority of cases this will be every 3 months. The only change is that when they come to follow up the patients will be asked to fill in the same interventional questionnaire (designed to assess post-transplant lung health) that the interventional arm are completing. However, they will be seen regardless of what this questionnaire reports.
This will act as validation for the questionnaire. The interventional arm will replace the 3 monthly visits with a questionnaire which the patient will be asked to complete and then this will be returned to the unit. The patient can fill this in via the app, or on paper and return the questionnaire via email or post. The duty clinician will then review the questionnaire and combine this with the home spirometry data which the patient is already completing to see if the patient needs to be seen. In the majority of cases, its expected that the patient will not need to be seen as the clinic visits in lung transplant are mainly monitored and the vast majority of the patients are seen every 3-4 months. Regardless of the outcome, the participant will receive a phone call from the transplant nurse within 48 hours of the appointment to discuss the results of the blood test and confirm that they are okay.
In addition to the questionnaire to assess lung health, all participants will be asked to complete other respiratory/sleep questionnaires such as Saint George's Respiratory (SGRQ), Morningness-eveningness (MEQ-SA) and the Pittsburgh Sleep Quality Index (PSQI). This will investigate whether more complex questionnaires are needed to see if patients require clinical follow-up. Study duration is predicted to be 6 months per participant. During the whole study, volunteers will be asked to wear an activity tracker such as Fitbit. Using the device's application programming interface (API) investigators will be able to remotely access data concerning heart rate, accelerometry and sleep duration, including stages of sleep. This will be accessed as required anticipated to be once per week, followed by phone calls to patients should the data be missing. In addition, their clinical record will also be accessed to obtain clinical data for instance if a sleep study has been performed. Patients will be asked to perform daily home spirometry using a Bluetooth enabled spirometer. It is currently being used in the Manchester lung transplant program. If patients have not submitted a reading for one week then they will be contacted by the study team to offer assistance.
- Conditions
- Lung Transplant; Complications
- Being tested
- Hybrid care arm, Standard of care arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid care armOther
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).
Standard of care armOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Hybrid care arm | Experimental | Remote review of information collected electronically will be combined with in person visits at a hospital Receives: Other: Hybrid care arm |
| Standard of care arm | Active comparator | Patients will be seen in person at a hospital clinic. Receives: Other: Standard of care arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clinic visits per patient
The number of clinic follow up visits in the observation period
Measured: 6 months
Secondary outcomes (6)
Number of unplanned clinic visits per patient
The number of unplanned clinic visits in the observation period
Measured: 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
Frequency of use at ≥ 1 day/week
Measured: 6 months
Hospitalisation due to deterioration of allograft function
Number of patients hospitalised due to deterioration of allograft function
Measured: 6 Months
Duration of hospitalisations due to deterioration of allograft function
Number of hospitalised days due to deterioration of allograft function
Measured: 6 Months
Number of planned clinic visits per patient
The number of planned clinic visits in the observation period
Measured: 6 Months
Number of patients where symptoms were recorded accurately on the questionnaire
The number of patients where a clinician recorded that symptoms were recorded accuratly
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start29 Sep 2023
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- patientMpower Ltd., Manchester University NHS Foundation Trust, University College, London, New Start, The Wythenshawe Hospital Transplant Fund Centre
- Responsible party
- Principal investigator, John Blaikley, University of Manchester
- Investigators
- John Blaikley, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916495
- Sponsor's protocol ID
- LTX patientMpower 01
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Final results of the study will be disseminated in the form of a manuscript/s in a peer-reviewed journal scientific journals, presented at national and international conferences and in local meetings. In addition, where relevant, data from potential interim analyses will be presented at (a) relevant congress (es).
Publications
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.
PubMed 41073612
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Remote Care (Questionnaire+Hybrid) in Patients Who Are Post-lung Transplant
- ClinicalTrials.gov ID
- NCT05916495
- Acronym / sponsor ID
- LTX patientMpower 01
- Conditions
- Lung Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- patientMpower Ltd., Manchester University NHS Foundation Trust, University College, London, New Start, The Wythenshawe Hospital Transplant Fund Centre
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
100 lung transplant patients are expected to be recruited. Consent will be taken by the research team. Following admission they will be randomised to the interventional or control arms. The control arm will consist of follow-up according to unit policy, in the majority of cases this will be every 3 months. The only change is that when they come to follow up the patients will be asked to fill in the same interventional questionnaire (designed to assess post-transplant lung health) that the interventional arm are completing. However, they will be seen regardless of what this questionnaire reports.
This will act as validation for the questionnaire. The interventional arm will replace the 3 monthly visits with a questionnaire which the patient will be asked to complete and then this will be returned to the unit. The patient can fill this in via the app, or on paper and return the questionnaire via email or post. The duty clinician will then review the questionnaire and combine this with the home spirometry data which the patient is already completing to see if the patient needs to be seen. In the majority of cases, its expected that the patient will not need to be seen as the clinic visits in lung transplant are mainly monitored and the vast majority of the patients are seen every 3-4 months. Regardless of the outcome, the participant will receive a phone call from the transplant nurse within 48 hours of the appointment to discuss the results of the blood test and confirm that they are okay.
In addition to the questionnaire to assess lung health, all participants will be asked to complete other respiratory/sleep questionnaires such as Saint George's Respiratory (SGRQ), Morningness-eveningness (MEQ-SA) and the Pittsburgh Sleep Quality Index (PSQI). This will investigate whether more complex questionnaires are needed to see if patients require clinical follow-up. Study duration is predicted to be 6 months per participant. During the whole study, volunteers will be asked to wear an activity tracker such as Fitbit. Using the device's application programming interface (API) investigators will be able to remotely access data concerning heart rate, accelerometry and sleep duration, including stages of sleep. This will be accessed as required anticipated to be once per week, followed by phone calls to patients should the data be missing. In addition, their clinical record will also be accessed to obtain clinical data for instance if a sleep study has been performed. Patients will be asked to perform daily home spirometry using a Bluetooth enabled spirometer. It is currently being used in the Manchester lung transplant program. If patients have not submitted a reading for one week then they will be contacted by the study team to offer assistance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid care arm | Experimental | Other: Hybrid care armRemote review of information collected electronically will be combined with in person visits at a hospital |
| Standard of care arm | Active comparator | Other: Standard of care armPatients will be seen in person at a hospital clinic. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Looked after by a clinical care team at Manchester University NHS Foundation Trust
- Given consent
- Have received a lung transplant
Key exclusion criteria (2 listed)
- Consent not given
- Not able to operate the remote monitoring platform
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid care armPatients 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 | Hybrid care arm |
| Standard of care armPatients 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). | Other | Standard of care arm |
Primary outcome
Number of clinic visits per patient
Time frame: 6 months
The number of clinic follow up visits in the observation period
6 secondary outcomes
Number of unplanned clinic visits per patient
Time frame: 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
Time frame: 6 months
Hospitalisation due to deterioration of allograft function
Time frame: 6 Months
Duration of hospitalisations due to deterioration of allograft function
Time frame: 6 Months
Number of planned clinic visits per patient
Time frame: 6 Months
Number of patients where symptoms were recorded accurately on the questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41073612Varley 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.
- Individual participant dataSharing planned: No. Final results of the study will be disseminated in the form of a manuscript/s in a peer-reviewed journal scientific journals, presented at national and international conferences and in local meetings. In addition, where relevant, data from potential interim analyses will be presented at (a) relevant congress (es).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Blaikley principal investigator
The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid care arm in people with Lung Transplant; Complications, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clinic visits per patient (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.