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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
4
Participants will be asked to use the app and connected devices daily for 3 months.
Medicines Optimisation Innovation Centre
Antrim, United Kingdom
Participants' engagement with the SHAPES app during the pilot
The number of times the app is opened per day
Time frame: 3 months (end of pilot)
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.
Time frame: 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.
Time frame: 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.
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
Rate defined as number of pairs of limits generated per week during the pilot
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Number and rate of heart failure decompensation scores generated
Time frame: 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.
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
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.
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
Measured via qualitative interview
Time frame: 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
Time frame: 3 months (end of pilot)
Exploration of participants' views about their trust and acceptance of the SHAPES app
Measured via qualitative interview
Time frame: 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.
Time frame: 3 months (end of pilot)
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