NCT04675554

Brief Summary

This study will be a non-interventional study intended to identify psychological antecedents of the acceptability of WeWard application among people aged 55 years and older, , and its impacts on engagement in physical activity. Participants will be included in the study on a voluntary basis and healthy volunteers will be registered on the national volunteer database. This study will include people aged over 55 from senior citizens associations, from patients coming for frailty consultations at the Cimiez University Hospital Centre, and from any senior living in France. Regarding the recruitment, application users will receive a request to participate in a scientific study. If the request is accepted, participants will fill in the non-opposition form via the application and will complete, with their smartphone, a series of psychometric questionnaires (e.g. level of physical activity, personality, motivation, perceived physical competence, new technologies acceptability, etc.). Participants will then use the mobile application for a period of 12 weeks during which time, physical activity data provided from participants smartphone will be gathered such as the number of steps or gait speed. Psychometric questionnaires comprising each time one item (i.e. ecological momentary assessment) will be administered to participants randomly, in order to assess their evolution. After the 12 weeks of using the mobile application, older people will answer to the same series of psychometric questionnaires administered at the beginning of the study. Finally,lparticipants who will drop out the trial during this study will be contacted in order to clarify the reasons for their withdrawal.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

December 9, 2020

Last Update Submit

January 23, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • number of steps from a mobile application :

    number of steps

    during 12 weeks

  • walking speed from a mobile application

    walking speed

    during 12 weeks

  • walking distance from a mobile application

    walking distance

    during 12 weeks

  • change of level from a mobile application

    change of level

    during 12 weeks

  • Big Five Inventory

    Big Five Inventory: score 1 to 5 when agree, item score is 5 when disagree, item score is 1

    before and after 12 weeks of using the application.

  • Perceived physical self worth

    Perceived physical self worth: one item score : very bad to very good

    before and after 12 weeks of using the application.

Interventions

participants will fill in the non-opposition form via the application and will complete, with their smartphone, a series of psychometric questionnaires. Participants will then use the mobile application for a period of 12 weeks during which time, physical activity data provided from participants smartphone will be gathered After 12 weeks, participants will complete again the same series of psychometric questionnaires.

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all person using the application

You may qualify if:

  • signed non opposition
  • \> or = 55 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Olivier GUERIN, PU-PH

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic CHORIN, PhD

CONTACT

Olivier GUERIN, PU-PH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 19, 2020

Study Start

February 1, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

January 25, 2023

Record last verified: 2023-01