Organ TransplantORCHARDNCT05732922
ORCHARD- Optimising Home Assessment of Rural Patients
A study testing A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers. in people with Organ Transplant and Cancer, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This project assesses feasibility of providing medically vulnerable rural patients with Medical-Self-Assessment-Boxes containing equipment to use at home during telephone and video consultations (telemedicine) with GPs and other healthcare professionals. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Organ Transplant, Cancer, Inborn Errors of Metabolism
- What is being tested?
- A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to 31 Aug 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● Solid organ transplant recipient
- On the COVID-19 shielding list
- People with specific cancers
- People with cancer who had chemotherapy within the last 2 years
- People with lung cancer that have had radical radiotherapy within the last two years
- People with cancer of the blood or bone marrow such as leukaemia, lymphoma or myeloma who are at end stage treatment
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- People that have had immunotherapy or other continuing antibody treatments for cancer within the last two years
- People that had other targeted cancer treatment which can affect the immune system, such as protein kinase inhibitors or PARP inhibitors within the last two years
- People who had bone marrow or stem cell transplants in the last 6 months, or who are still taking immunosuppression drugs
- People with severe respiratory conditions including all cystic fibrosis, severe asthma, and severe COPD
- People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as SCID, homozygous sickle cell anaemia)
- People in immunosuppression therapies sufficient to significantly increase risk of infection
- A GP working at the pilot study practice and carried out telemedicine consultations with participants
- A GP who can provide informed consent
Who cannot join
- People whose GP feels they are not able to participate in the research. People unable to consent to participate. Non-English speakers
- A GP that cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen
Aberdeen, Aberdeen City, AB25 2ZD
About this study
Official title: Optimising Remote Consulting and Home Assessment of Medically Vulnerable Rural Patients During Unscheduled and Planned Primary Care- Assessing Feasibility of the ORCHARD Intervention
This project assesses feasibility of providing medically vulnerable rural patients with Medical-Self-Assessment-Boxes containing equipment to use at home during telephone and video consultations (telemedicine) with GPs and other healthcare professionals. COVID-19 has caused an upsurge in primary care telemedicine which the investigators believe can be sustained and optimized to make things better for medically vulnerable rural patients beyond the pandemic. The investigators will achieve this by equipping the participants to self-measure and report key clinical measurements (e.g. blood pressure, temperature, oxygen levels) during telemedicine consultations. Before conducting a major evaluation of the Medical-Self-Assessment-Box for medically vulnerable rural patients the investigators must establish three things: First, to show the investigators can issue a Medical-Self-Assessment-Box to medically vulnerable rural patients and enable them to use it properly. Second, to determine that patients can use the Medical-Self-Assessment-Box effectively during telemedicine consultations. Third, to show that it is possible to measure how well the Medical-Self-Assessment-Box is working by counting how often the boxes are being used and whether use is appropriate and helpful. The knowledge gained will provide the investigators with the information needed to develop a funding proposal to evaluate Medical-Self-Assessment-Boxes for medically vulnerable rural patients in the whole of the UK.
- Conditions
- Organ Transplant, Cancer, Inborn Errors of Metabolism, Immunosuppression, COPD Asthma, Sickle Cell Disease
- Being tested
- A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.
- Keywords
- telemedicine, rurality, diagnostic equipment, vulnerable patients
- Medical subject headings
- Neoplasms, Metabolism, Inborn Errors, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.Device
A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants in the intervention arm to use during their telemedicine consultations with health care providers.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will be receiving their standard medical care. |
| Intervention | Active comparator | Participants will be receiving the intervention on top of their standard medical care. Receives: Device: A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short questionnaire
The questionnaire will assess use of equipment, perception of how helpful the equipment was for the consultation and the reasons why it was helpful.
Measured: 6 months (given at the end of every TM consultation)
Interviews
Qualitative data collected at the end of the study according to a topic guide.
Measured: 1 day (end of study interview)
Secondary outcomes (7)
Number of consultations face to face
Number of face to face consultations
Measured: 6 months (every time there is a consultation)
Number of consultations TM
Number of telemedicine consultations
Measured: 6 months (every time there is a consultation)
Hospital admissions elective
Number of elective hospital admissions
Measured: 6 months (every time there is an admission)
Hospital admissions emergency
Number of emergency hospital admissions
Measured: 6 months (every time there is an admission)
Ambulance service call-outs
Number of Scottish ambulance service call-outs
Measured: 6 months (every time there is a call-out)
Ambulance service paramedics
Number of face-to-face paramedic assessment
Measured: 6 months (every time there is an assessment)
Survival
Survival at six months
Measured: 6 months (assessed at the end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Feb 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Murchie, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732922
- Sponsor's protocol ID
- 310499
- Acronym
- ORCHARD
- Status last verified
- Mar 2025
- First submitted
- 25 Oct 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Remote Consulting and Home Assessment of Medically Vulnerable Rural Patients During Unscheduled and Planned Primary Care- Assessing Feasibility of the ORCHARD Intervention
- ClinicalTrials.gov ID
- NCT05732922
- Acronym / sponsor ID
- ORCHARD / 310499
- Conditions
- Organ Transplant, Cancer, Inborn Errors of Metabolism, Immunosuppression, COPD Asthma, Sickle Cell Disease
- Keywords
- telemedicine, rurality, diagnostic equipment, vulnerable patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 17 Feb 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.
This project assesses feasibility of providing medically vulnerable rural patients with Medical-Self-Assessment-Boxes containing equipment to use at home during telephone and video consultations (telemedicine) with GPs and other healthcare professionals. COVID-19 has caused an upsurge in primary care telemedicine which the investigators believe can be sustained and optimized to make things better for medically vulnerable rural patients beyond the pandemic. The investigators will achieve this by equipping the participants to self-measure and report key clinical measurements (e.g. blood pressure, temperature, oxygen levels) during telemedicine consultations. Before conducting a major evaluation of the Medical-Self-Assessment-Box for medically vulnerable rural patients the investigators must establish three things: First, to show the investigators can issue a Medical-Self-Assessment-Box to medically vulnerable rural patients and enable them to use it properly. Second, to determine that patients can use the Medical-Self-Assessment-Box effectively during telemedicine consultations. Third, to show that it is possible to measure how well the Medical-Self-Assessment-Box is working by counting how often the boxes are being used and whether use is appropriate and helpful. The knowledge gained will provide the investigators with the information needed to develop a funding proposal to evaluate Medical-Self-Assessment-Boxes for medically vulnerable rural patients in the whole of the UK.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will be receiving their standard medical care. |
| Intervention | Active comparator | Device: A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.Participants will be receiving the intervention on top of their standard medical care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ● Solid organ transplant recipient
- A GP working at the pilot study practice and carried out telemedicine consultations with participants
- A GP who can provide informed consent
Key exclusion criteria (2 listed)
- People whose GP feels they are not able to participate in the research. People unable to consent to participate. Non-English speakers
- A GP that cannot provide informed consent
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 |
|---|---|---|
| A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants in the intervention arm to use during their telemedicine consultations with health care providers. | Device | Intervention |
Primary outcome
Short questionnaire
Time frame: 6 months (given at the end of every TM consultation)
The questionnaire will assess use of equipment, perception of how helpful the equipment was for the consultation and the reasons why it was helpful.
Interviews
Time frame: 1 day (end of study interview)
Qualitative data collected at the end of the study according to a topic guide.
7 secondary outcomes
Number of consultations face to face
Time frame: 6 months (every time there is a consultation)
Number of consultations TM
Time frame: 6 months (every time there is a consultation)
Hospital admissions elective
Time frame: 6 months (every time there is an admission)
Hospital admissions emergency
Time frame: 6 months (every time there is an admission)
Ambulance service call-outs
Time frame: 6 months (every time there is a call-out)
Ambulance service paramedics
Time frame: 6 months (every time there is an assessment)
Survival
Time frame: 6 months (assessed at the end of the study)
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 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Peter Murchie principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers. in people with Organ Transplant and Cancer, run by University of Aberdeen 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 14 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 30 Mar 2025. 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?
Short questionnaire (time frame: 6 months (given at the end of every TM consultation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.