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Completed

NCT Number: NCT05732922

ORCHARD- Optimising Home Assessment of Rural Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ● 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
  • 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

Inclusion criteria

for GPs:

  • A GP working at the pilot study practice and carried out telemedicine consultations with participants
  • A GP who can provide informed consent

Exclusion criteria

  • People whose GP feels they are not able to participate in the research. People unable to consent to participate. Non-English speakers

Exclusion criteria

for GPs:

A GP that cannot provide informed consent

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Interviews

    Time frame: 1 day (end of study interview)

    Qualitative data collected at the end of the study according to a topic guide.

Secondary outcomes

  1. Number of consultations face to face

    Time frame: 6 months (every time there is a consultation)

    Number of face to face consultations

  2. Number of consultations TM

    Time frame: 6 months (every time there is a consultation)

    Number of telemedicine consultations

  3. Hospital admissions elective

    Time frame: 6 months (every time there is an admission)

    Number of elective hospital admissions

  4. Hospital admissions emergency

    Time frame: 6 months (every time there is an admission)

    Number of emergency hospital admissions

  5. Ambulance service call-outs

    Time frame: 6 months (every time there is a call-out)

    Number of Scottish ambulance service call-outs

  6. Ambulance service paramedics

    Time frame: 6 months (every time there is an assessment)

    Number of face-to-face paramedic assessment

  7. Survival

    Time frame: 6 months (assessed at the end of the study)

    Survival at six months

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

Optimising Remote Consulting and Home Assessment of Medically Vulnerable Rural Patients During Unscheduled and Planned Primary Care- Assessing Feasibility of the ORCHARD Intervention

Acronym: ORCHARD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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