Smart Living Homes: GATEKEEPER System With Patients With Cancer and Dementia in Cyprus

NCT05490524 | Unknown

• 1 other identifier: CUT_DN_01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the Project is to create a GATEKEEPER, that connects healthcare providers, businesses, entrepreneurs, elderly citizens and the communities they live in, in order to originate an open, trust-based arena for matching ideas, technologies, user needs and processes, aimed at ensuring healthier independent lives for the ageing populations. By 2022, GATEKEEPER will be embodied in an open source, European, standard-based, interoperable and secure framework available to all developers, for creating combined digital solutions for personalised early detection and interventions that (i) harness the next generation of healthcare and wellness innovations; (ii) cover the whole care continuum for elderly citizens, including primary, secondary and tertiary prevention, chronic diseases and co-morbidities; (iii) straightforwardly fit "by design" with European regulations, on data protection, consumer protection and patient protection (iv) are subjected to trustable certification processes; (iv) support value generation through the deployment of advanced business models based on the VBHC paradigm. GATEKEEPER will demonstrate its value by scaling up, during a 42-month work plan, towards the deployment of solutions that will involve ca 40.000 elderly citizens, supply and demand side (authorities, institutions, companies, associations, academies) in 8 regional communities, from 7 EU member states. Recently 3 Asian pilots have been added as a result of the Open Calls. The achievement of the overall objective is supported by the following, among others, specific objective: To execute a series of PILOTS to demonstrate the effect, benefit, value and scalability of the GATEKEEPER solutions around REFERENCE USE CASES COVERING PRIMARY, SECONDARY and TERTIARY PREVENTION, initially deployed in 8 regions of 7 European countries. The Cyprus pilot mainly focuses on the early detection of the condition worsening of cancer and dementia patients by monitoring whether the use of technology can trigger appropriate management, thereby reducing the need for higher acuity care, and even, at times, improving survival by supporting demand-driven solutions through high-quality health mobile systems.

Conditions

Neoplasms; Cancer; Dementia

Keywords

cancer; digital health; dementia; eHealth; RCT

Outcome Measures

Primary Outcomes (2)

• Health Related Quality of Life (cancer patients only)

  EORTC QLQ C-30 is a cancer health-related quality-of-life questionnaire that has been widely validated and used in clinical trials and investigations using PROs for individual patient management. It is composed of both multi-item scales and single-item measures. The QLQ-C30 will be administered at admission and at 6 weeks. It is hypothesized that the improvement will he higher for the full intervention group patients compared to the limited intervention group patients.

  Baseline and follow up at 6 weeks

• Health status (dementia patients only)

  EQ-5D is a standardised measure of health status to provide a simple, generic measure of health for clinical and economical appraisal. The EQ-5D provides a simple descriptive profile and a single summary index value for health status. The EQ-5D will be administered at admission and at 6 weeks.

  Baseline and follow up at 6 weeks

Secondary Outcomes (13)

• Symptom burden (cancer patients only)

  Baseline and follow up at 6 weeks

• Anxiety (cancer patients only)

  Baseline and follow up at 6 weeks

• Depression (cancer patients only)

  Baseline and follow up at 6 weeks

• System Usability

  Follow up at 6 weeks

• System Feasibility

  Follow up at 6 weeks

Other Outcomes (1)

• Activity tracker

  Daily data for 6 weeks

Study Arms (3)

Control group

NO INTERVENTION

The Control group will receive standard health care with no technical support, where the intervention groups will receive platform and device services provided to each user. In that respect, Intervention Group 1 will receive no real-time feedback, where Intervention Group 2 will unhand with real data and notifications. A control group is defined as a group of clinical trial participants who will not be provided any digital devices as part of the trial and will receive care as usual by PASYKAF and AMEN.

Intervention group 1 (limited technology)

EXPERIMENTAL

Intervention Group 1 - platform/devices (no real feedback provided (limited technology group) A limited technology group is defined as a group of clinical trial participants who receive the digital devices but not the automated interventions through the devices (prompts, messages).

Device: GATEKEEPER

Intervention group 2 (full technology)

EXPERIMENTAL

Intervention Group 2 -platform/devices (with real feedback provided) (full technology group) A full technology group is defined as a group of clinical trial participants who receive the digital devices as part of the trial and healthcare professionals receive the patients' data.

Device: GATEKEEPER

Interventions

GATEKEEPER DEVICE

The GATEKEEPER is a digital platform that allows patients and caregivers to record their day-to-day symptoms and other parameters such as quality of life using means such as apps and wearable devices that record both self-report (quality of life, depression, anxiety) and physiological data (mobility, pain, sleep patterns, heart rate), and allows healthcare professionals to monitor these data and tailor healthcare so to prevent and intervene in symptoms that may be occurring.

Intervention group 1 (limited technology); Intervention group 2 (full technology)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged: Over the age of 50 years
• Adequate understanding of Greek and/or English Language
• Cancer diagnosis/ ICD-10: Illness classification system
• Functional status/ ECOG Performance Status 0,1,2,3
• ECOG Performance Status 4 only if Phase of Illness and Prognosis permits
• Phase of illness (Based on Medical Assessment and presenting prognosis/ the Patient is expected by the Health Care Team to be able to complete the 6-week study period)
• Patient receiving Health Care Services from PASYKAF

You may not qualify if:

• Aged \< 50 years
• Psychiatric diagnosis
• Over the age of 18 years
• Adequate understanding of Greek and/or English Language
• Primary caregiver of patient with cancer
• Patient/ Caregiver receiving Health Care Services from PASYKAF (The primary caregiver is a family member or friend that supports a patient through cancer treatment, helps with daily activities, such as going to the doctor or preparing meals, coordinates services and care and provides emotional and spiritual support, www.cancer.gov)
• Aged \< 18 years
• Not able to consent
• PASYKAF employed Health Care Professionals( Nurses, Psychologists, Social Workers and Physiotherapists) that provide services in all districts of Cyprus (Nicosia, Limassol, Larnaca, Paralimni, Pafos)
• Adequate understanding of Greek and/or English Language

Sponsors & Collaborators

• Cyprus University of Technology: lead
• Pancyprian Federation of Cancer Patients and Friends: collaborator

Study Sites (1)

Cyprus University of Technology

Limassol, 3036, Cyprus

RECRUITING

MeSH Terms

Conditions

Neoplasms; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Angelos P. Kassianos, PhD

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelos P. Kassianos, PhD

CONTACT

0035725002252; angelos.kassianos@cut.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, research assistants, nurses, social workers, physiotherapists and psychologists responsible for data collection will not have access to the information of which group (control or intervention) the participant is.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The Control group will receive standard health care with no technical support, where the intervention groups will receive platform and device services provided to each user. In that respect, Intervention Group 1 will receive no real-time feedback, where Intervention Group 2 will unhand with real data and notifications. group)

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: June 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CY (1)