SHAPES: Supporting Multimorbid Older People

NCT05249062 | Completed

• 3 other identifiers: NT21-SHAPES857159284743
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Diabetes; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Participants' engagement with the SHAPES app during the pilot

  The number of times the app is opened per day

  3 months (end of pilot)

Secondary Outcomes (16)

• Participants' user experience with the SHAPES app

  3 months (end of pilot)

• Usability of the SHAPES app

  3 months (end of pilot)

• Number and rate of successful registrations of each clinical parameter per participant, per day

  3 months (end of pilot)

• Number and rate of control limits (upper and lower) successfully generated by the 'Vitals Control' analytic tool per person

  3 months (end of pilot)

• Number and rate of heart failure decompensation prediction (HFPred) risk scores successfully generated per person

  3 months (end of pilot)

Other Outcomes (12)

• Participants' self-efficacy as measured using the General Self-Efficacy Scale

  Baseline, 3 months (end of pilot) and follow-up (further 3 months)

• Participants' extent of social support

  Baseline, 3 months (end of pilot) and follow-up (further 3 months)

• Participants' health literacy

  Baseline, 3 months (end of pilot) and follow-up (further 3 months)

Study Arms (1)

intervention

EXPERIMENTAL

The intervention being piloted in this study is a novel system of supporting older individuals with multiple long-term conditions to self-manage their chronic conditions through the daily use of a digital health product that can also facilitate the remote monitoring of a person's health status.

Device: SHAPES app

Interventions

SHAPES app DEVICE

Participants will be asked to use the app and connected devices daily for 3 months.

intervention

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Prof Michael Scott: lead
• Mid and East Antrim Agewell Partnership (MEAAP): collaborator
• University of Nicosia: collaborator
• Vicomtech: collaborator
• TREE Technology S.A.: collaborator
• National University of Ireland, Maynooth: collaborator
• Gnomon Informatics S.A.: collaborator
• Edgeneering LDA: collaborator
• Fraunhofer-Institute of Toxicology and Experimental Medicine: collaborator
• University of Ulster: collaborator

Study Sites (1)

Medicines Optimisation Innovation Centre

Antrim, BT41 2RL, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Scott

  Northern Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Michael Scott

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 21, 2022
• Study Start: February 9, 2023
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)