Clinical trial NCT02663856: My Smart Age With HIV: Smartphone Self-assessment of Frailty
Official title: My Smart Age With HIV (MySAwH): Smartphone Self-assessment of Frailty and Information - Communication Technology to Promote Healthy Ageing in HIV.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection
Aging
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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:

-

Primary outcomes:
measure: Measure change of frailty index
timeFrame: 18 months
measure: Measure Multi-morbidity
timeFrame: 18 months
measure: Measure Physical Function
timeFrame: 18 months
measure: Measure Cognition impairment
timeFrame: 18 months
measure: Measure disability
timeFrame: 18 months
measure: Measure quality of life
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Clinica Metabolica, Ambulatorio HIV, A.O.U. Policlinico di Modena
Study officials:
affiliation: University of Modena and ReggioEmilia
name: Giovanni Guaraldi, Prof
role: PRINCIPAL_INVESTIGATOR
References: