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ORCHARD- Optimising Home Assessment of Rural Patients (ORCHARD)

Primary Purpose

Organ Transplant, Cancer, Inborn Errors of Metabolism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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.
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Organ Transplant focused on measuring telemedicine, rurality, diagnostic equipment, vulnerable patients

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Control

    Intervention

    Arm Description

    Participants will be receiving their standard medical care.

    Participants will be receiving the intervention on top of their standard medical care.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Number of consultations face to face
    Number of face to face consultations
    Number of consultations TM
    Number of telemedicine consultations
    Hospital admissions elective
    Number of elective hospital admissions
    Hospital admissions emergency
    Number of emergency hospital admissions
    Ambulance service call-outs
    Number of Scottish ambulance service call-outs
    Ambulance service paramedics
    Number of face-to-face paramedic assessment
    Survival
    Survival at six months

    Full Information

    First Posted
    October 25, 2022
    Last Updated
    February 8, 2023
    Sponsor
    University of Aberdeen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05732922
    Brief Title
    ORCHARD- Optimising Home Assessment of Rural Patients
    Acronym
    ORCHARD
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aberdeen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Organ Transplant, Cancer, Inborn Errors of Metabolism, Immunosuppression, COPD Asthma, Sickle Cell Disease
    Keywords
    telemedicine, rurality, diagnostic equipment, vulnerable patients

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants will be receiving their standard medical care.
    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    Participants will be receiving the intervention on top of their standard medical care.
    Intervention Type
    Device
    Intervention Name(s)
    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.
    Intervention Description
    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 Outcome Measure Information:
    Title
    Short questionnaire
    Description
    The questionnaire will assess use of equipment, perception of how helpful the equipment was for the consultation and the reasons why it was helpful.
    Time Frame
    6 months (given at the end of every TM consultation)
    Title
    Interviews
    Description
    Qualitative data collected at the end of the study according to a topic guide.
    Time Frame
    1 day (end of study interview)
    Secondary Outcome Measure Information:
    Title
    Number of consultations face to face
    Description
    Number of face to face consultations
    Time Frame
    6 months (every time there is a consultation)
    Title
    Number of consultations TM
    Description
    Number of telemedicine consultations
    Time Frame
    6 months (every time there is a consultation)
    Title
    Hospital admissions elective
    Description
    Number of elective hospital admissions
    Time Frame
    6 months (every time there is an admission)
    Title
    Hospital admissions emergency
    Description
    Number of emergency hospital admissions
    Time Frame
    6 months (every time there is an admission)
    Title
    Ambulance service call-outs
    Description
    Number of Scottish ambulance service call-outs
    Time Frame
    6 months (every time there is a call-out)
    Title
    Ambulance service paramedics
    Description
    Number of face-to-face paramedic assessment
    Time Frame
    6 months (every time there is an assessment)
    Title
    Survival
    Description
    Survival at six months
    Time Frame
    6 months (assessed at the end of the study)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria Ntessalen
    Phone
    +44 (0) 1224437263
    Email
    maria.ntessalen@abdn.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Murchie
    Phone
    +44 (0)1224437222
    Email
    p.murchie@abdn.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Murchie
    Organizational Affiliation
    University of Aberdeen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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