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

• Conditions: Aging; HIV Infection

• Registration Number: NCT02663856
• Lead Sponsor: University of Modena and Reggio Emilia

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.

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Study Start: 2016-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure Multi-morbidity	18 months	Assed by physician, based on the presence of 2 or more co-morbidities (hypertension, diabetes, cardiovascular disease, etc)
Measure quality of life	18 months	Assed using quality of life questionnaire
Measure change of frailty index	18 months	Assed by MySAwH application
Measure disability	18 months	Assed using disability questionnaire
Measure Physical Function	18 months	Assed using a Short Physical Performance Battery
Measure Cognition impairment	18 months	Assed using neurocognitive tests

Trial Locations

Locations (1)

Clinica Metabolica, Ambulatorio HIV, A.O.U. Policlinico di Modena; 🇮🇹 Modena, Italy