Pilot Study to Assess the Impact of a Mobile Health Application (App) on Clinical Outcomes and Satisfaction of Older HIV-Infected Patients, as an Emerging Tool for Care, Education and Prevention.

NCT04137016 | Completed

• 1 other identifier: APP-Age
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, HIV care has been reframed by the concepts of the HIV care and prevention. The success of these strategies will depend on integrated prevention and care system and sustained behavioral modification. The HIV infection is a chronic disease and the improved survival in HIV patients favours the emergence of new long-term morbidities associated with treatment and/or the virus itself. In high-income countries, approximately 30% of all adults living with HIV are aged 50 years and over. In 2015, 50% of HIV-infected patients will be over 50 years of age. Health plans are a priority to prevent this accelerated and accentuated process. The development of mobile devices such as smartphones and tablet computers has spurred rapid growth in the field of mobile health, the use of mobile-enabled applications that collect or deliver health care information and data. These applications offer the potential for dynamic engagement of patients and providers in health care and a new means of improving health outcomes. This technology could have profound application in the prevention or in the treatment of patients with chronic disease such as diabetes, obesity, HIV, etc, since these diseases are generating more health spending worldwide. The rapid growth in health has outpaced the needed to validate the clinical effectiveness of these applications. For this reason, we propose a study to assess the benefit of a specific App on the management of HIV-infected population aged 60 years or older It is a Randomized clinical trial, including 2 groups: 1) an experimental group comprising patients using the app + routine medical care and 2) a control group. The usability of the app and patient satisfaction were evaluated in the app group at weeks 24 and 48. Quality of life, adherence to treatment, and clinical parameters were compared in both groups at 48 weeks.

Conditions

HIV-1 Infection

Keywords

APP, old

Outcome Measures

Primary Outcomes (2)

• The number of clinical events or comorbidities between the 2 groups

  from baseline to week 48

• change in bone mineral density Prevention

  (BMD, lumbar and hip T-scores and Z-scores) measured by DXA scan.

  from baseline to week 48

Secondary Outcomes (6)

• To compare patient satisfaction in the app group

  Since baseline to week 48

• Usability of App

  Since baseline to week 48

• Identify the most frequently used items in the app

  From baseline to week 48

• Quality of life (Global, physical, mental and social)

  From baseline to Week 48

• adherence

  From baseline to Week 48

Other Outcomes (7)

• Changes in blood pressure,

  From baseline to week48

• Changes in glycemia

  From baseline to week48

• Changes in weight

  The number of clinical visits at the HIV unit, and hospitalizations.

Study Arms (2)

HIV-subjects with APP

EXPERIMENTAL

HIV-infected patients using the App + standard clinical management (SCM)

Other: Mobile application

Control group

NO INTERVENTION

HIV-infected patients, who only receive Standard Clinical Management (without the App)

Interventions

Mobile application OTHER

HIV-subjects with APP

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infected patients (≥60 years).
• Patients in antiretroviral treatment
• Patients who have and are used to a smartphone
• Patient who agree to participate in the study and signed informed consent

You may not qualify if:

• \- Patients with conditions that hampered understanding and use of mobile applications

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead

Study Sites (1)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08018, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• EUGÈNIA NEGREDO, PhD, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 23, 2019
• Study Start: December 15, 2016
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: December 6, 2019

Record last verified: 2019-10

Locations

ES (1)