Health Promotion Community-based Intervention Among Elderly People Through Self-managed MAHA Mobile App.

NCT05614479 | Unknown

• 1 other identifier: 857223
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

The GATEKEEPER project, funded by the European Commission's HORIZON 2020 innovation framework, aims to ensure healthier independent living for ageing populations. To this end, GATEKEEPER aims to develop an open, European-wide, standards-based, interoperable and secure platform, available to all stakeholders (healthcare professionals, technology companies and users), offering digital solutions on the Internet of Things, Big Data or Artificial Intelligence, or new techniques, for early detection and personalised interventions to ensure healthier independent living for ageing populations. GATEKEEPER will demonstrate its value by scaling up innovative solutions, during a 48-month work plan that will involve 40.000 elderly citizens, as well as authorities, institutions, companies, associations and academic centres from 8 pilot regions in 7 EU Member States. The pilots sites will deploy and demonstrate the effect, benefit, value and scalability of GATEKEEPER solutions around reference use cases covering primary, secondary and terciary prevention in the Basque Country (Spain), Aragon (Spain), Attica and Central Greece (Greece), Cyprus (Cyprus), Lodz (Poland), Milton Keynes (UK), Puglia (Italy) and Saxony (Germany). The Basque Country pilot site is involved in the Reference Use Cases focused to "Lifestyle-related early detection". The intervention aims to encourage active and healthy ageing by the use of a self-managed mobile application, thereby to enhance independence, autonomy and improve the well-being of older people, promoting their physical, cognitive and mental activity and social participation. This quasi-experimental and longitudinal study is target to 10,000 older people and/or their caregivers from the Basque Country region. A multi-channel and community-based recruitment strategy at Basque regional level has been designed that involves 39 community-based organizations from the Basque Health Ecosystem.

Conditions

Healthy; Chronic Disease

Keywords

Health promotion; Community based intervention; Healthy habits; Healthy lifestyle; Wellbeing; Innovative solutions; Quality of life; Self-care; Maintaining functionality; Active ageing; Empowerement; Educative health materials; Health literacy; Socialization; Community; Ageing; Older people

Outcome Measures

Primary Outcomes (2)

• Changes in Quality of Life by EuroQoL-5D

  EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  Change from baseline quality of life at 6 months

• Get up from the chair 5 times test

  The Get up from your chair 5 times test is aimed at measuring the participant's functionality. It assesses the muscular power of the lower limbs during the exercise of getting up and sitting down from the chair.

  Change from baseline result of the test at 6 months

Secondary Outcomes (2)

• App Usability Questionnaire MAUQ

  Up to 6 months

• App usage by users

  Up to 12 months

Study Arms (1)

Intervention group

OTHER

Use of the MAHA mobile application

Other: GATEKEEPER intervention

Interventions

GATEKEEPER intervention OTHER

Agents will identify candidates in their areas of work (e.g., associations of elderly people). Training sessions will be held for healthcare professionals and community agents. Dissemination of materials, resources, and channels to contact and inform candidates to invite them to participate in the study. Recruitment procedures posters, leaflets, videos, newsletters, or appointments will be used. Candidates interested and accepted will download the application on their mobile devices and will surf on the app which pretends to promote healthy aging. Users will provide some data and complete questionnaires (available in the application) for the baseline and final assessment. Professionals will visualize how and how much participants are interacting by using the MAHA dashboard.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects are eligible for the study if they are:
• years of age or older and/or their caregiver, family members and reference people
• With stable internet access and at least one of the following devices to use the GATEKEEPER application: Smartphone or Tablet
• They or their informal caregivers understand, read and talk the native language.

You may not qualify if:

• Patients are not eligible for recruitment if:
• Aged \< 65 years
• Do not have access to internet or at least one of the following devices to use the GATEKEEPER application: Smartphone or Tablet
• The informal caregiver will be a person who provides occasional or regular support to the participant. Caregivers are eligible if:
• They have stable internet access and at least one of the following devices to use the GATEKEEPER application: Smartphone or Tablet
• open to the use of new technology. They should be willing to learn how to use technology to support users if needed.

Sponsors & Collaborators

• Biosistemak Institute for Health Systems Research: lead
• Basque Health Service: collaborator

Study Sites (1)

Irati

Barakaldo, Bizkaia, 48902, Spain

RECRUITING

Related Links

• Webpage of GATEKEEPER project

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ane Fullaondo Zabala

  Biosistemak Institute for Health Systems Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irati Erreguerena Redondo

CONTACT

+34 944007799; ierreguerena@kronikgune.org

Ane Fullaondo Zabala

CONTACT

+34 944007792; afullaondo@kronikgune.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A quasi-experimental, longitudinal (pre-post, prospective and without a control group). This research is not a clinical trial, but a technology testing study at community level (community intervention). Therefore, the health and medical treatments provided to the person do not differ from those provided to the participants. Nevertheless, the participant is entitled to know of any unexpected discoveries or findings as part of research conducted in a study, just as if the individual were not participating in the study. The mixed-method approach will provide scientific evidence based on the effectiveness, and user experience of a self-managed mobile health application that recommends activities to promote healthy lifestyle habits.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: November 14, 2022
• Study Start: April 20, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)