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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04675554
Other study ID # 20-PP-23
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2023
Est. completion date February 2025

Study information

Verified date January 2023
Source Centre Hospitalier Universitaire de Nice
Contact Frederic CHORIN, PhD
Phone 0492034924
Email chorin.f@chu-nice.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1500
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: - signed non opposition - > or = 55 years old Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Follow up of physical activity
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice Côte d'Azur Université, Laboratoire Motricite´ Humaine, Expertise, Sport, Sante´ (LAMHESS)

Outcome

Type Measure Description Time frame Safety issue
Primary number of steps from a mobile application : number of steps during 12 weeks
Primary walking speed from a mobile application walking speed during 12 weeks
Primary walking distance from a mobile application walking distance during 12 weeks
Primary change of level from a mobile application change of level during 12 weeks
Primary 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.
Primary 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.
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