Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2016 by Giovanni Guaraldi, University of Modena and Reggio Emilia

Sponsor
University of Modena and Reggio Emilia


Information provided by (Responsible Party)
Giovanni Guaraldi, University of Modena and Reggio Emilia

ClinicalTrials.gov Identifier
NCT02663856

First received: January 19, 2016
Last updated: December 7, 2016
Last Verified: December 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infection
Aging

Other : observational

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: My Smart Age With HIV (MySAwH): Smartphone Self-assessment of Frailty and Information - Communication Technology to Promote Healthy Ageing in HIV.

Further study details as provided by Giovanni Guaraldi, University of Modena and Reggio Emilia:

Primary Outcome Measures

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

Estimated Enrollment: 300
Study Start Date: September 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study: 50 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02663856

Contacts

Contact:   Giovanni Guaraldi, Prof giovanni.guaraldi@unimore.it

Locations

Italy
Clinica Metabolica, Ambulatorio HIV, A.O.U. Policlinico di Modena Recruiting
Modena, Italy, 41124
Contact: Giovanni Guaraldi, Prof, MD    giovanni.guaraldi@unimore.it

Sponsors and Collaborators

University of Modena and Reggio Emilia

Investigators

Principal Investigator: Giovanni Guaraldi, Prof University of Modena and ReggioEmilia
More Information

More Information


Responsible Party: Giovanni Guaraldi, MD, University of Modena and Reggio Emilia  
ClinicalTrials.gov Identifier: NCT02663856   History of Changes  
Other Study ID Numbers: MySAwH  
Study First Received: January 19, 2016  
Last Updated: December 7, 2016  
Individual Participant Data    
Plan to Share IPD: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 13, 2017
This information is provided by ClinicalTrials.gov.