ORCHARD- Optimising Home Assessment of Rural Patients

NCT05732922 | Completed

• 1 other identifier: 310499
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Transplant; Cancer; Inborn Errors of Metabolism; Immunosuppression; COPD Asthma; Sickle Cell Disease

Keywords

telemedicine; rurality; diagnostic equipment; vulnerable patients

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 day (end of study interview)

Secondary Outcomes (7)

• Number of consultations face to face

  6 months (every time there is a consultation)

• Number of consultations TM

  6 months (every time there is a consultation)

• Hospital admissions elective

  6 months (every time there is an admission)

• Hospital admissions emergency

  6 months (every time there is an admission)

• Ambulance service call-outs

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

Study Arms (2)

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.

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen

Aberdeen, Aberdeen City, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Metabolism, Inborn Errors; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies

Study Officials

• Peter Murchie

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: February 17, 2023
• Study Start: February 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

GB (1)