ORCHARD- Optimising Home Assessment of Rural Patients

Trial Title: ORCHARD- Optimising Home Assessment of Rural Patients

NCT ID: NCT05732922

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

Conditions: Official terms:
Anemia, Sickle Cell
Metabolism, Inborn Errors

Conditions: Keywords:
telemedicine
rurality
diagnostic equipment
vulnerable patients

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: 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.
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.
Arm group label: Intervention

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Start date: February 2023

Completion date: August 2023

Lead sponsor:
Agency: University of Aberdeen
Agency class: Other

Source: University of Aberdeen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05732922