ORCHARD- Optimising Home Assessment of Rural Patients

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05732922
• Other study ID #: 310499
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: August 2023

Study information

• Verified date: February 2023
• Source: University of Aberdeen
• Contact: Maria Ntessalen
• Phone: +44 (0) 1224437263
• Email: maria.ntessalen[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Cancer
• COPD Asthma
• Immunosuppression
• Inborn Errors of Metabolism
• Metabolism, Inborn Errors
• Organ Transplant
• Sickle Cell Disease

Intervention

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.
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Interviews	Qualitative data collected at the end of the study according to a topic guide.	1 day (end of study interview)
Secondary	Number of consultations face to face	Number of face to face consultations	6 months (every time there is a consultation)
Secondary	Number of consultations TM	Number of telemedicine consultations	6 months (every time there is a consultation)
Secondary	Hospital admissions elective	Number of elective hospital admissions	6 months (every time there is an admission)
Secondary	Hospital admissions emergency	Number of emergency hospital admissions	6 months (every time there is an admission)
Secondary	Ambulance service call-outs	Number of Scottish ambulance service call-outs	6 months (every time there is a call-out)
Secondary	Ambulance service paramedics	Number of face-to-face paramedic assessment	6 months (every time there is an assessment)
Secondary	Survival	Survival at six months	6 months (assessed at the end of the study)