SHAPES: Supporting Multimorbid Older People

NCT ID: NCT05249062

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2023-06-16

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Diabetes Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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intervention

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.

Group Type EXPERIMENTAL

SHAPES app

Intervention Type DEVICE

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

Interventions

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SHAPES app

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mid and East Antrim Agewell Partnership (MEAAP)

UNKNOWN

Sponsor Role collaborator

University of Nicosia

OTHER

Sponsor Role collaborator

Vicomtech

UNKNOWN

Sponsor Role collaborator

TREE Technology S.A.

UNKNOWN

Sponsor Role collaborator

National University of Ireland, Maynooth

OTHER

Sponsor Role collaborator

Gnomon Informatics S.A.

UNKNOWN

Sponsor Role collaborator

Edgeneering LDA

UNKNOWN

Sponsor Role collaborator

Fraunhofer-Institute of Toxicology and Experimental Medicine

OTHER

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role collaborator

Prof Michael Scott

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof Michael Scott

Prof Michael Scott

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Scott

Role: PRINCIPAL_INVESTIGATOR

Northern Health and Social Care Trust

Locations

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Medicines Optimisation Innovation Centre

Antrim, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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857159

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

284743

Identifier Type: OTHER

Identifier Source: secondary_id

NT21-SHAPES

Identifier Type: -

Identifier Source: org_study_id

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