June 18, 2020 Uncategorized

Requirements for pilot sites

AAL Programme

Proiect  – SAfety of elderly people and Vicinity Ensuring – “SAVE”

Deliverable: D.3.1 Requirements for pilot sites

Version: V1.0

WP3 Leader: VSRO

Table of contents

 

  1. General information
  2. Introduction
  3. Legal reference and regulatory frameworks
  4. Informed-consent procedure
  5. Recruitment phase
  6. Pilot register
  7. Technical inspection
  8. Evaluation
  9. Conditions in recruiting end-users
  10. Questionnaires proposal to be analyzed by the project partners
  11. Preliminary requirements of the Technology Club system – the well-being component

11.1. Preliminary definition of the concept

11.2. Preliminary System Requirements (PSR)

11.3. Preliminary test / validation plan

CONTENT

A preliminary assessment phase is needed to assess different models (laws, policies, home care services) and further local constraints (e.g., need of ethical application) possibly impacting on pilot implementation.

 

  1. General information

In nowadays, most of the elderly people they start to have mobile telephones, but without home sensors in their home, only 44% of Romanian population between 55 and 74 years old are using internet (Romanian Statistical Institute), 30% of them are using more than 3 months. For elderly people, over 65 years, we have data from 2013, when only 16% of Romanian population over 65 years had internet at home. Therefore the human computer interaction is new for almost all the elderly that will be integrated in the project.

Our concern is to discuss with the psychologists about recruiting process of end-users, specially the questionnaire evaluation, interviews, focus group. The meetings topic will concentrate to identify the best tool for recruiting the end-users and how the SAVE concept will be able to be part of pilots group until the end of the project.

 

  1. Introduction

As previously declared, the main ethical concerns involved in the AAL framework are: privacy, control of personal data, confidentiality, autonomy and dignity, and such an issues must be explored in relation with the use of innovative ICT solutions that can be complex to manage for end users and caregivers.

At a general level, the ethical project’s guidelines, are:

  • participation on a voluntary basis
  • protection of end-user’s identity from third parties
  • data collection and storage in anonymized databases
  • strict application of the European and national regulations
  • full information of all the involved parties (end users, formal and informal caregivers)
  • right to cancellation on first demand
  • each pilot will be supervised by a coordinator, in order to ensure a prompt intervention in case of need or in case of request by any stakeholder

 

  1. Legal reference and regulatory frameworks

The legal references for the pilot implementation are linked to the base principles af any scientific experimentation protocol, as Nuremberg Code, Helsinki Declaration, Charter on the Fundamental Human Rights in the EU, UNESCO Declaration on the responsibilities of the present Generations Towards the Future Generations, Ethics and EU funded research Council Decision 1513/2002/EC on FP6.).

The most relevant principles we refer to, are the following:

  • user’s voluntary consent will be ensured by the means of a “informed-consent form”. Voluntary participation implies that the user must not be forced and joined the project on its own initiative
  • experimentation is aimed at finding solution dedicated to improving the quality of life of users. Testing activities are proportionate to the objectives to be achieved: there are no risks of death or serious injury to users. The project will ensure that the experimentation will be conducted so as not to damage the users (both physically and psychologically)
  • all the people involved in the project will be professional and qualified operators
  • if during the implementation of the project unforeseen ethical concerns arise, it will be the responsibility of the project partners to bring the matter to the attention of the Project Coordinator for an ethics review: the theme in question will be analyzed and, if needed, it will be identified the appropriate solution to avoid any kind of risk to the user
  • users can leave the experiment at any time and testing will be interrupted, if there are reason to believe that the continuation would violate the principles listed above

Given this perspective, all the pilots will be set and implemented submitting to the European and national regulations. Main European reference is the REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

 

  1. Informed-consent procedure

“Informed-consent” is a process, devised in health care framework, in order to obtain and manage permission before an intervention regarding any person, in order to guarantee total confidentiality and privacy. Every national pilot site adopts a specific informed-consent form, which will be submitted to, explained to and signed by the selected users before the test’s start.

 

  1. Recruitment phase

According to the target profile guidelines, the national End-user partner will identify the end-users to involve in the experimentation, gathering information, if necessary with the help and the authorization of the Public Service case-manager or the private care giving manager assisting the elderly.

Our concern is to discuss this topic with the specialists from the field about recruiting process of end-users, specially the questionnaire evaluation, interviews and focus group. The meetings topic will concentrate to identify the best tool for recruiting the end-users and how the SAVE concept will be able to be part of pilots group until the end of the project.

Once the user has been identified, the coordinator and partners will arrange a first meeting with the end-users and caregivers to explain the project aims and goals, the experimentation procedures, and to evaluate weather his actual living situation (social and health needs, home environment, eligibility criteria, etc.) fits the requirement standards and conduct the formal agreement signature. The end-user monitoring starts with the investigations of assessing the level of behaviors used in daily activities. The areas that we should investigated will be: communication; using community resources; functional behaviors; health and safety; self – care; family life; social interaction; digital skills; physical activity. The questionnaires next with the interviews will support an individual report for each pilot, where the individual strength and/or weak points are determined. These general reports will be discuss with the professional caregiver to identify the current state of daily life for each pilot.

 

 

 

  1. Pilot register

A register of the active pilots will be issued to better manage the experimentation and to share evidences or information with the other national sites.

 

  1. Technical inspection

After reaching the agreement, the End-user partner will: a) set the pilot roadmap b) arrange the technical inspection for the installation of the devices and c) developed the technology club system.

 

  1. Evaluation

The evaluation consists of qualitative data, coming from short interviews with the elderly. Evaluation is based on:

  • Intake survey
  • Survey in between
  • End survey
  • Group discussion

 

  1. Conditions in recruiting end-users:
  • voluntary in the target group
  • living alone
  • internet connection in their home
  • history (clinical)

 

  1. Questionnaires proposal to be analyzed by the project partners
Name Clinical Scales Time Evaluation Country Validity
ABAS II

Adaptive Behavior Assessment System

www.testcentral.ro

 

Communication;

The use of

community resources;

Functional behaviors

Family life;

Health and safety;

Leisure;

Self-care;

Social behavior.

30 minutes Provides the possibility of assessing the level of behaviours used in daily activities by people over the age of 65. Romania and Italy validity

To be verified in Hungary

CASE – SF

Clinical Assessment Scales for the Elderly

Anxiety;

Cognitive competence;

Depression;

Fear of aging;

Obsessive-compulsive;

Paranoia;

Psychoticism;

Somatization;

Mania;

Substance abuse

40 minutes Assess for the most prominent DSM-IV disorders among the elderly. Romanian validity
QUALIDEM

Dementia-specific quality of

life instrument for persons

 

Dichter et al., 2016

Care relationship

Positive affect

Negative affect

Restless tense behavior

Positive self image

Social relations

Social isolations

Feeling at home

Having something to do

5 minute Measure the level of dementia

 

 
UTAUT

Unified Theory of Acceptance and Use of Technology Model

Sundaravej, 2004

 

Performance expectancy

Effort expectancy

Social influences

Facilitating conditions

Behavior intention

 

 

10 minute Acceptance and Use of Technology No validity for over 65 years old
MMSE

Mini Mental State Examination

 

Dodge et al., 2009

10 sub Items  – 5-10 Minute Screening scale for global cognition or general mental status No validity information in project countries
Katz ADL

Katz Index of Independence in Activities of Daily Living

 

Wallace, 2008

6 items – activities

Bathing

Dressing

Toileting

Transferring

Continence

Feeding

Depends of the end-user Independence in Activities of Daily Living  
I.A.D.L

Instrumental  activities of daily living scale

 

Graf C., 2008

8 scales

Ability to use telephone

Shopping

Food preparation

Laundry

Mode of transportation

Responsibility for own medications

Depends of the end-user Instrumental  activities of daily living No validity information in project countries
GADL

General Activities of Daily Living Scale

 

de Paula et al. 2014

3 scales

ADLs self care

ADLs domestic

ADLs complex

10 minute measure of activities of daily living for older people No validity information in project countries
ASCOT

Adult Social Care Outcomes Toolkit

 

 

van Leeuwen et al., 2015

Control over daily life

Personal cleanliness and comfort

Food and drink

Personal safety

Social participation and involvement

Occupation

Accommodation cleanliest and comfort

Dignity filter question

ASCOT dignity question

10 minute information about an individual’s social

care-related quality of life

 

 

 

  1. Preliminary requirements of the Technology Club system – the well-being component

 

11.1. Preliminary definition of the concept

The SAVE project aims to implement the Technology Club – the well-being component, a service that aims to ensure the well-being of the targeted users – people over 50 suffering from chronic age-related illnesses, mild cognitive problems / disabilities or cognitive decline using monitoring. physical condition and stress with portable devices. P3 – The Institute of Space Sciences is responsible for designing the Technology Club – the well-being component, as stated in WP1, Task 1.8 of the project proposal.

According to the user’s requirements, the Technology Club – the well-being component must have the ability to monitor the activity of walking (TC10), the quality of sleep (TC9) and the level of stress (TC8), as well as the option of monitoring the physical condition, combining social life (TC4, TC5) with daily activities (TC3, TC4) to maintain / improve the well-being of the elderly.

The preliminary concept of the Technology Club – the well-being component is presented in Figure 1.

 

Fig. 1. The Technology Club concept – the well-being component

 

  • Preliminary System Requirements (PSR)
Nr. Preliminary System Requirement Requirement type Traceability
1. PSRTC1. The system must be able to monitor the physical activity of the subject. Functional requirement TC7
2. PSRTC2. The system must be portable. Interface Requirement TC2
3. PSRTC3. The system should have a maximum weight of 200 grams. Physical constraint TC2
4. PSRTC4. The system should be compatible with Android / iOS operating systems. Interface Requirement SC3
5. PSRTC5. The system should have a charging dock. Functional requirement TC2
6. PSRTC6. The system must have a travel adapter. Functional requirement TC2.
7. PSRTC7. The system must use at least the Bluetooth 4.0 protocol. Interface Requirement SC3
8. PSRTC8. The system must be waterproof. Environmental requirement TC2
9. PSRTC9. The system must monitor the number of steps. Functional requirement TC10
10. PSRTC10. The system must monitor the distance traveled by walking. Functional requirement TC10
11. PSRTC11. The system should monitor the quality of sleep. Functional requirement TC9
12. PSRTC12. The system must monitor the pulse. Functional requirement CS4
13. PSRTC13. The system should monitor incoming telephone calls. Functional requirement SC3
14. PSRTC14. The system must monitor the stress level. Functional requirement TC8
15. PSRTC15. The system should require recharging the battery for at least 3 days. Functional requirement TC2
16. PSRTC16. The system must send the parameters registered to a cloud service. Functional requirement CS6, SC7
17. PSRTC17. The system must be able to connect to the internet. Functional requirement SC7

 

  • Preliminary test / validation plan
PSR Component Evaluation type
PSRTC 14 Stress tracker Inspection and testing of physical elements
PSRTC9, PSRTC10 Physical activity tracker Inspection and testing of physical elements
PSRTC 11 Sleep quality tracker Inspection and testing of physical elements
Toate PSR Technology Club: the well-being component System inspection and testing

 

The components of the Technology Club will be verified by independent inspections and tests on the physical elements. All the components mentioned in the above table will be tested and inspected “in-house” from the perspective of the Technology Club.

The validation plan of the well-being component, as an independent system, will be carried out in two stages, namely:

  • Internal validation of the well-being component;
  • Validation of the pilot study of the well-being component based on the feedback of end users.

 

 

REFERENCES

http://www.insse.ro/cms/files/statistici/comunicate/com_anuale/tic/tic_r2013.pdf

http://www.insse.ro/cms/sites/default/files/com_presa/com_pdf/tic_r2017_0.pdf

 

 

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