My Smart Age With HIV: Smartphone Self-assessment of Frailty

NCT ID: NCT02663856

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-06-30

Brief Summary

Understanding the complexity of aging and frailty in chronic HIV infection motivated Italian team members to begin to build a frailty index (FI) including 37 health variables at the Modena HIV Metabolic Clinic (MHMC). The validation of FI in HIV patients have been recently published, and more data comparing FI in HIV infected vs un-infected people, have been presented at international meeting and are at present submitted for publication.

The research consortium (MHMC, HCC and HHMP) of this study was motivated to begin preliminary work in consideration of the similar multidisciplinary approach in Ageing care and capacity to address health status in ageing HIV patients using shared definitions of co-morbidities, multi-morbidity and measures of Physical Function and Cognition impairment, disability and quality of life. The investigators wanted to overcome the major criticism intrinsic in the FI, that is the needs to collects many variables not easily available in most HIV centres. The the investigators approach is to make patient living with HIV (PLWH), be the source of health variables taking advantage of information and communication technologies available with smart phones and fitness tracking device, collecting physiological parameters and patient related outcomes.

Detailed Description

In this study the investigators plan to empower elderly HIV patients via health promotion, assessing reduction in health deficit and improvement in quality of life using My Smart Age (MySAwH) application.

MySAwH is an interactive mobile application designed to empower elderly HIV patients in health promotion through self assessment of ageing transition using a FI. FI is generated from health variables which include physical function data routinely collected by fitness tracking devices, Ecological momentary assessment data collected with smart phones and Physician health data collected during patient visits. The change in frailty index over time describes health transition. Although health generally worsens with age, the relationship between aging and health is dynamic and periodic improvement and stability in frailty index may be the result of the patients engagement in health promotion and improved life style.

Conditions

HIV Infection; Aging

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

observational

Self assessment of ageing transition using a frailty index through MySAwH app

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HIV infection on ART
• HIV1-RNA<40 c/mL for at least 6 months
• Age stratification:

• 50 pts (per centre) aged 50-64 years
• 50 pts (per centre) aged ≥ 65 years
• Routine access to a smart phone and willingness to use the fitness tracking device
• Willingness to be trained to use an interactive mobile application

Exclusion Criteria

-

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Guaraldi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Guaraldi, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Modena and ReggioEmilia

Locations

Clinica Metabolica, Ambulatorio HIV, A.O.U. Policlinico di Modena

Modena, , Italy

Countries

Italy

Other Identifiers

MySAwH

Identifier Type: -

Identifier Source: org_study_id