Heart FailureNCT05249062
SHAPES: Supporting Multimorbid Older People
A study testing SHAPES app in people with Heart Failure and Diabetes, run by Prof Michael Scott at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Heart Failure, Diabetes, Diabetes Mellitus
- What is being tested?
- SHAPES app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2023to 16 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Participant report of cognitive impairment
- Wears an electronic medical device or implant (e.g. pacemaker, electrocardiogram)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medicines Optimisation Innovation Centre
Antrim, BT41 2RL
About this study
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
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.
Read more
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
- Being tested
- SHAPES app
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAPES appDevice
Participants will be asked to use the app and connected devices daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SHAPES app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' engagement with the SHAPES app during the pilot
The number of times the app is opened per day
Measured: 3 months (end of pilot)
Secondary outcomes (16)
Participants' user experience with the SHAPES app
Measured using the User Experience Questionnaire -short version (UEQ-S) A score of -3 to 3 is generated for each participant. A higher score indicates a positive user experience.
Measured: 3 months (end of pilot)
Usability of the SHAPES app
Measured using the System Usability Scale A score of 0 to 100 is generated for each participant. A higher score indicates better usability.
Measured: 3 months (end of pilot)
Number and rate of successful registrations of each clinical parameter per participant, per day
Measured by determining the number of successful registrations of each clinical parameter, per participant, per day (i.e., actual measure of clinical parameter is not relevant to this outcome).
Findings presented as a percentage of total number of expected registrations a day i.e., 0 to 100% success rate for each parameter.
Measured: 3 months (end of pilot)
Number and rate of control limits (upper and lower) successfully generated by the 'Vitals Control' analytic tool per person
Rate defined as number of pairs of limits generated per week during the pilot
Measured: 3 months (end of pilot)
Number and rate of heart failure decompensation prediction (HFPred) risk scores successfully generated per person
Rate defined as number of scores generated per week during the pilot
Measured: 3 months (end of pilot)
Change in hospitalisation rate per person (hospitalisations/month) and A&E attendance rate (attendance/month)
Change in hospitalisation rate per person (hospitalisations/month) and A\&E attendance rate (attendance/month)
Measured: Three months prior to baseline compared with 3 months during the pilot
Participants' self-reported medication adherence
Measured using the Medication Adherence Report Scale (MARS) A score between 5 and 25 is generated for each participant. A higher score indicates better adherence.
Measured: Baseline and 3 months (end of pilot)
Participants' beliefs about medicines
Measured using the Belief's about Medicines Questionnaire (BMQ) There are two scales in this outcome. The Necessity Scale assesses beliefs about personal need for medicines. The Concerns Scale assesses medication concerns.
A score between 5-25 is generated for each scale for each participant.
The two scores are amalgamated to produce the Necessity Concerns Differential (subtract Concerns Score from the Necessity Score) to give a score between -20 and 20. Higher scores indicate stronger beliefs in the necessity of medication and fewer concerns about taking it.
Measured: Baseline and 3 months (end of pilot)
Correlation between participants' self-reported medication adherence and beliefs about medicines
The correlation between participants' self-reported medication adherence as measured using the Medication Adherence Report Scale (see outcome 8) and their Belief's about Medicine's Questionnaire- Necessity Concerns Differential (see outcome 9) will be measured statistically using an appropriate correlation coefficient (Pearson correlation coefficient OR Spearman's Rank Order correlation coefficient).
Note: the study will not be powered to show statistical significance of the correlation but will indicate a possible strength and direction of the relationship.
Measured: 3 months (end of pilot)
Number and rate (score/week) of heart failure decompensation prediction (HFPred) risk scores successfully generated per person during the pilot
Number and rate of heart failure decompensation scores generated
Measured: 3 months (end of pilot)
Correlation between HFPred scores and unscheduled care during the pilot
An appropriate statistical test will be performed to determine whether, or not, there is a correlation between incidence of unscheduled care use (unscheduled care defined as composite of hospitalisations, A\&E attendances, specialist contacts, out-of-hours contacts) and heart failure decompensation prediction (HFPred) risk scores.
Note: the study will not be powered to show statistical significance of the correlation but will indicate a possible strength and direction of the relationship.
Measured: 3 months (end of pilot)
Health-related quality of life as measured using the EuroQol 5 dimension 5 level (EQ-5D-5L) descriptive system and visual analogue scale
The EuroQol 5 dimension 5 level (EQ-5D-5L) questionnaire will be used to describe the five dimensions of health related quality of life (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION) for each participant.
Each of the five dimensions comprising the EQ-5D descriptive system is divided into five levels of perceived problems:
LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems.
A unique health state is defined by combining one level from each of the five dimensions. A total of 3125 possible health states is defined in this way. Each state is referred to by a 5-digit code.
The visual analogue scale records the participants' self-rated health on a vertical visual analogue scale between 0 and 100. Higher scores indicate better perceived health.
Measured: Baseline and 3 months (end of pilot)
Exploration of healthcare practitioners' views on integration and alignment of the SHAPES platform and Digital Solutions with current care pathways
Measured via qualitative interview
Measured: 3 months (end of pilot)
Exploration of healthcare practitioners' views about their trust and acceptance of the SHAPES platform and Digital Solutions
Measured via qualitative interview
Measured: 3 months (end of pilot)
Exploration of participants' views about their trust and acceptance of the SHAPES app
Measured via qualitative interview
Measured: 3 months (end of pilot)
Exploration of user engagement behaviors
Measured via cross-comparative exploratory analysis of user event logs and qualitative interviews with participants.
Measured: 3 months (end of pilot)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start9 Feb 2023
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Michael Scott
- Sponsor type
- Other government
- Collaborators
- Mid and East Antrim Agewell Partnership (MEAAP), University of Nicosia, Vicomtech, TREE Technology S.A., National University of Ireland, Maynooth, Gnomon Informatics S.A., Edgeneering LDA, Fraunhofer-Institute of Toxicology and Experimental Medicine, University of Ulster
- Responsible party
- Sponsor-investigator, Prof Michael Scott, Northern Health and Social Care Trust
- Investigators
- Michael Scott, Principal investigator, Northern Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249062
- Sponsor's protocol ID
- NT21-SHAPES
- Other IDs
- 857159, 284743
- Status last verified
- Jul 2023
- First submitted
- 15 Dec 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05249062
- Acronym / sponsor ID
- NT21-SHAPES
- Conditions
- Heart Failure, Diabetes, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Prof Michael ScottOther government
- Collaborators
- Mid and East Antrim Agewell Partnership (MEAAP), University of Nicosia, Vicomtech, TREE Technology S.A., National University of Ireland, Maynooth, Gnomon Informatics S.A., Edgeneering LDA, Fraunhofer-Institute of Toxicology and Experimental Medicine, University of Ulster
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: SHAPES appThe 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
- Has stable self-reported Wi-Fi connection at home
Key exclusion criteria (2 listed)
- Participant report of cognitive impairment
- Wears an electronic medical device or implant (e.g. pacemaker, electrocardiogram)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAPES appParticipants will be asked to use the app and connected devices daily for 3 months. | Device | intervention |
Primary outcome
Participants' engagement with the SHAPES app during the pilot
Time frame: 3 months (end of pilot)
The number of times the app is opened per day
16 secondary outcomes
Participants' user experience with the SHAPES app
Time frame: 3 months (end of pilot)
Usability of the SHAPES app
Time frame: 3 months (end of pilot)
Number and rate of successful registrations of each clinical parameter per participant, per day
Time frame: 3 months (end of pilot)
Number and rate of control limits (upper and lower) successfully generated by the 'Vitals Control' analytic tool per person
Time frame: 3 months (end of pilot)
Number and rate of heart failure decompensation prediction (HFPred) risk scores successfully generated per person
Time frame: 3 months (end of pilot)
Change in hospitalisation rate per person (hospitalisations/month) and A&E attendance rate (attendance/month)
Time frame: Three months prior to baseline compared with 3 months during the pilot
Participants' self-reported medication adherence
Time frame: Baseline and 3 months (end of pilot)
Participants' beliefs about medicines
Time frame: Baseline and 3 months (end of pilot)
Correlation between participants' self-reported medication adherence and beliefs about medicines
Time frame: 3 months (end of pilot)
Number and rate (score/week) of heart failure decompensation prediction (HFPred) risk scores successfully generated per person during the pilot
Time frame: 3 months (end of pilot)
Correlation between HFPred scores and unscheduled care during the pilot
Time frame: 3 months (end of pilot)
Health-related quality of life as measured using the EuroQol 5 dimension 5 level (EQ-5D-5L) descriptive system and visual analogue scale
Time frame: Baseline and 3 months (end of pilot)
Exploration of healthcare practitioners' views on integration and alignment of the SHAPES platform and Digital Solutions with current care pathways
Time frame: 3 months (end of pilot)
Exploration of healthcare practitioners' views about their trust and acceptance of the SHAPES platform and Digital Solutions
Time frame: 3 months (end of pilot)
Exploration of participants' views about their trust and acceptance of the SHAPES app
Time frame: 3 months (end of pilot)
Exploration of user engagement behaviors
Time frame: 3 months (end of pilot)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Scott principal investigator
Northern Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHAPES app in people with Heart Failure and Diabetes, run by Prof Michael Scott at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' engagement with the SHAPES app during the pilot (time frame: 3 months (end of pilot)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023; AzTrials last refreshed its copy on 30 Oct 2026.