Clinical trial NCT05249062: SHAPES: Supporting Multimorbid Older People
Official title: A Non-randomised Pilot Study of the Smart and Healthy Ageing Through People Engaging in Supportive Systems (SHAPES) Digital App and Platform for Supporting Medicines Optimisation in Older Individuals With Multiple Long-term Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Diabetes
Diabetes Mellitus
Lead sponsor: Northern Health and Social Care Trust
Sponsor class: OTHER_GOV
Collaborators: name: Mid and East Antrim Agewell Partnership (MEAAP)
name: University of Nicosia
name: Vicomtech
name: TREE Technology S.A.
name: National University of Ireland, Maynooth
name: Gnomon Informatics S.A.
name: Edgeneering LDA
name: Fraunhofer-Institute of Toxicology and Experimental Medicine
name: University of Ulster
First posted: 2022-02-21
Enrollment: 4
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Smart \& Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Innovation Action is a Horizon 2020, EU-wide project looking at how technology can enable the older population to live healthier lives at home. It involves the development, piloting and deployment of a large scale, EU-standardised open platform. This platform will integrate with a wide-range of technological, organisational, clinical, educational and societal solutions seeking to facilitate long-term healthy and active aging.

Within this project are 7 pilot themes investigating various potential uses of the platform, in Northern Ireland we are leading on medicines control and optimisation.

This pilot is focused on identifying, managing and improving deficiencies in adherence to medicines and treatments of older individuals living with permanent or temporary reduced functions or capabilities due to chronic, age-related illnesses and living at home. Digital Solutions (including blood pressure monitors, pulse oximeters, weight scales and glucometers) will be used to enable self-monitoring of the individual's physiological parameters. Data will also be used to develop an algorithm to help predict decompensations in participants with heart failure and dynamic personal ranges will also be developed. In the future this may enable early opportunities to adjust medicines and treatments so as to deliver safer and more effective use of medicines in-home, however, in this pilot there will be no changes to treatment.

The target population is composed of older individuals (+65 years) living at home with heart failure and/or diabetes. We aim to recruit 30 people (for 3 months) to our pilot in Northern Ireland. We are working closely with colleagues in Spain, Czech Republic, Cyprus and Germany to run similar pilots within their healthcare systems.


Eligibility criteria: Inclusion Criteria:

* Northern Health and Social Care Trust service user
* ≥60 years
* Diagnosed with heart failure and/or diabetes mellitus (treatment includes regular self-monitoring of blood glucose)
* Lives at home or in supported living accommodation (category 1 or 2).

  * Category 1 - self-contained accommodation for the more active elderly, which may include an element of scheme supervisor support and/or additional communal facilities
  * Category 2 - scheme supervisor supported self-contained accommodation for the less active elderly, which includes the full range of communal facilities
* Has stable self-reported Wi-Fi connection at home
* Has access to an appropriate android smartphone or tablet
* Android device running version 8 or above; supports Wi-Fi; supports BLE; front facing camera for facial recognition
* Self-reported stable disease state, the participant feels well enough to take part in the pilot
* Self-reported confident user of smartphone/tablet

Exclusion Criteria:

* Participant report of cognitive impairment
* Wears an electronic medical device or implant (e.g. pacemaker, electrocardiogram)

Primary outcomes:
measure: Participants' engagement with the SHAPES app during the pilot
timeFrame: 3 months (end of pilot)
Secondary outcomes:
measure: Participants' user experience with the SHAPES app
timeFrame: 3 months (end of pilot)
measure: Usability of the SHAPES app
timeFrame: 3 months (end of pilot)
measure: Number and rate of successful registrations of each clinical parameter per participant, per day
timeFrame: 3 months (end of pilot)
measure: Number and rate of control limits (upper and lower) successfully generated by the 'Vitals Control' analytic tool per person
timeFrame: 3 months (end of pilot)
measure: Number and rate of heart failure decompensation prediction (HFPred) risk scores successfully generated per person
timeFrame: 3 months (end of pilot)
measure: Change in hospitalisation rate per person (hospitalisations/month) and A&E attendance rate (attendance/month)
timeFrame: Three months prior to baseline compared with 3 months during the pilot
measure: Participants' self-reported medication adherence
timeFrame: Baseline and 3 months (end of pilot)
measure: Participants' beliefs about medicines
timeFrame: Baseline and 3 months (end of pilot)
measure: Correlation between participants' self-reported medication adherence and beliefs about medicines
timeFrame: 3 months (end of pilot)
measure: Number and rate (score/week) of heart failure decompensation prediction (HFPred) risk scores successfully generated per person during the pilot
timeFrame: 3 months (end of pilot)
measure: Correlation between HFPred scores and unscheduled care during the pilot
timeFrame: 3 months (end of pilot)
measure: Health-related quality of life as measured using the EuroQol 5 dimension 5 level (EQ-5D-5L) descriptive system and visual analogue scale
timeFrame: Baseline and 3 months (end of pilot)
measure: Exploration of healthcare practitioners' views on integration and alignment of the SHAPES platform and Digital Solutions with current care pathways
timeFrame: 3 months (end of pilot)
measure: Exploration of healthcare practitioners' views about their trust and acceptance of the SHAPES platform and Digital Solutions
timeFrame: 3 months (end of pilot)
measure: Exploration of participants' views about their trust and acceptance of the SHAPES app
timeFrame: 3 months (end of pilot)
measure: Exploration of user engagement behaviors
timeFrame: 3 months (end of pilot)
Other outcomes:
measure: Participants' self-efficacy as measured using the General Self-Efficacy Scale
timeFrame: Baseline, 3 months (end of pilot) and follow-up (further 3 months)
measure: Participants' extent of social support
timeFrame: Baseline, 3 months (end of pilot) and follow-up (further 3 months)
measure: Participants' health literacy
timeFrame: Baseline, 3 months (end of pilot) and follow-up (further 3 months)
measure: Participation in society
timeFrame: Baseline, 3 months (end of pilot) and follow-up (further 3 months)
measure: Participants' quality of life score as measured using the World Health Organization Brief Quality of life tool (WHOQOL-BREF)
timeFrame: Baseline, 3 months (end of pilot) and follow-up (further 3 months)
measure: Health-related quality of life as measured using the EuroQol 5 dimension 5 level (EQ-5D-5L) descriptive system and visual analogue scale
timeFrame: Baseline and 3 months (end of pilot)
measure: Usability of the SHAPES app
timeFrame: 3 months (end of pilot)
measure: Technology Acceptance
timeFrame: 3 months (end of pilot)
measure: Exploration of participants' views about their trust and acceptance of the SHAPES platform and Digital Solutions
timeFrame: 3 months (end of pilot)
measure: Exploration of healthcare practitioners' views about their trust and acceptance of the SHAPES platform and Digital Solutions
timeFrame: 3 months (end of pilot)
measure: Change in health service utilisation for unscheduled care related to heart failure and diabetes
timeFrame: 3 months prior to baseline and 3 months (end of pilot)
measure: Economic impact of the intervention
timeFrame: 3 months (end of pilot)
Locations:
city: Antrim
country: United Kingdom
facility: Medicines Optimisation Innovation Centre
Study officials:
affiliation: Northern Health and Social Care Trust
name: Michael Scott
role: PRINCIPAL_INVESTIGATOR
References: