Participants aged >65 years with multiple co-morbidities, and/or frailty and/or recent episodes of unscheduled acute care Other
Conditions
Interventions
Daily biometric data are collected from patients who self monitor using certified medical devices and then capture the data using the Reassure app. Data on exacerbations are collected subsequently fro
Sponsors
NHS West Essex Clinical Commissioning Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >65 years 2. More than two comorbidities AND/OR 3. Medium or high frailty score AND/OR 4. More than one unscheduled urgent care attendances in the previous year
Exclusion criteria
Exclusion criteria: 1. Children 2. Individuals for whom consent cannot be obtained (i.e. individuals with mental impairments) 3. Individuals who have rare chronic conditions which cannot be monitored with the devices used in the study (e.g. complex musculoskeletal conditions like ankylosing spondylitis, liver failure patients) 4. Patients on palliative care 5. Individuals whose wellbeing might be compromised through the measurements, such as an individual with bullous skin disease or osteogenesis, imperfect with a blood pressure cuff 6. Individuals with mental health conditions whose wellbeing and care could be compromised by the introduction of measurements 7. Individuals living in locations significantly far away geographically from other prospective participants (e.g. in locations where domiciliary carers might not be able to cost-effectively reach to collect measurements) 8. Individuals who lose mental capacity during the study period will be removed from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are collected once daily for 12 weeks (unless otherwise stated) by participants self-measuring using devices selected for them by a qualified doctor using professional judgment following review of the participant's primary care record. Participants are asked to self-monitor daily but adherence to the requested frequency of measurements will vary between participants. These primary measures are: 1. Blood pressure – reported as systolic pressure in mmHg, diastolic pressure in mmHg, pulse in beats per minute, and measured using a CE-certified commercially available blood pressure monitor, data transcribed into the Reassure app running on iOS or Android smartphone or tablet and transferred via the internet to the L2S2 database. 2. Temperature – reported as degrees Centigrade and measured using a CE-certified commercially available forehead thermometer, data transcribed into the Reassure app running on iOS or Android smartphone or tablet and transferred via the internet to the L2S2 database. 3. Blood oxygen saturation – reported as a percentage of the maximum concentration of oxygen in blood and pulse in beats per minute and measured using a CE-certified commercially available pulse oximeter, data transcribed into the Reassure app running on iOS or Android smartphone or tablet and transferred via the internet to the L2S2 database. 4. Respiration rate – reported as breaths per minute and measured using the Reassure app (CE-certified medical device) and transferred via the internet to the L2S2 database 5. Urine protein – measured using Siemens Uristix, reported as negative, trace, 0.3, 1, 3, or =20 g of protein/litre urine. Reported by participant by assessing colour change visually and entering result into the Reassure app running on iOS or Android smartphone or tablet. The result is transferred via the internet to the L2S2 database 6. Urine ketones - measured using Siemens Ketostix, reported as negative, trace, 0.05, 0.15, 0.4, 0.8, or 1.6 g k | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dropout percentage defined as the ratio of the number of days on which readings were taken by participants divided by the number of days the person participates in the study (84 being 12 weeks). This measure is determined after 12 weeks of self-measurement by the participant. 2. Frailty score is as extracted from the participant’s medical record as the NHS electronic Frailty Index. The NHS Frailty Index is a risk stratification tool and frailty is confirmed using a validated tool such as the Gait Speed Test, PRISMA-7 or Timed Up and Go test. This measure is determined after 12 weeks of self-measurement by the participant. 3. Technical support calls, reported as the number of technical support calls made by trained Research Assistants to participants categorised by primary Complication Group. Technical support calls will be logged as they are made in the Reassure participant management system. Technical support calls will be categorised as: 3.1. Training the participant in the use of devices 3.2. Provision of additional training in the use of devices 3.3. Troubleshooting issues in the use of devices This measure is determined after 12 weeks of self-measurement by the participant. 4. Identification of participants feelings about being involved in the trial, including feedback on different aspects of the study. Aspects will include: 4.1. Participant Information Leaflet 4.2. Recruitment procedure 4.3. Equipment set up procedure 4.4. Use of devices 4.5. Provision of technical support by Research Assistant Feedback will be obtained by interviewing participants using qualitative and categorical questions to ascertain and categorise their feedback on the above aspects. This measure is determined after 12 weeks of self-measurement by the participant. 5. Identification of participants’ perception of positive or negative effects resulting from participation in the study. Participants will be asked to provide feedback through structured interviews on their perception of | — |
Countries
England, United Kingdom
Outcome results
None listed