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

Aging Clinical Trial

— MySAwH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02663856
• Other study ID #: MySAwH
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: June 2019

Study information

• Verified date: April 2019
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Aging
• Frailty
• HIV Infection
• HIV Infections

Intervention

Other:
• observational
Self assessment of ageing transition using a frailty index through MySAwH app

Locations

Country	Name	City	State
Italy	Clinica Metabolica, Ambulatorio HIV, A.O.U. Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

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