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

My Smart Age With HIV (MySAwH): Smartphone Self-assessment of Frailty and Information - Communication Technology to Promote Healthy Ageing in HIV.

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infection; Aging
• Intervention / Treatment: Other: observational

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41124
    • Clinica Metabolica, Ambulatorio HIV, A.O.U. Policlinico di Modena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In a prospective 24 months study, 300 consecutive HIV positive patients aged>50 years (100 per centre)will be enrolled to assess primary objective.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Investigators: Principal Investigator: Giovanni Guaraldi, Prof, University of Modena and ReggioEmilia

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: MySAwH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO