Effectiveness of a Multifactorial Intervention in Frailty Individuals With HIV Infection: HIDRA360 (HIDRA360)

September 4, 2023 updated by: Julian Olalla Sierra, Hospital Costa del Sol

Prevalence of Frailty in Individuals With HIV Infection and Age Older Than 60 Years, Factors Associated and 6-month Effectiveness of a Multifactorial Intervention: HIDRA360

The goal of this quasi-experimental before/after study without equivalent control group is to to describe the prevalence of frail, pre-fragile and robust individuals in the study group before and after a multifactorial intervention in in frail HIV patients.

The main questions it aims to answer are after a multifactorial intervention:

  1. To describe the sociodemographic, viroimmunological and ART exposure factors of fragile individuals compared to pre-fragile and robust individuals.
  2. To describe adherence to the Mediterranean diet in frail individuals compared to pre-frail and robust individuals.
  3. To describe the presence of anxiety and depression in frail individuals with respect to pre-fragile and robust individuals.
  4. To describe the analytical parameters and inflammatory markers of frail individuals with respect to pre-fragile and robust individuals.
  5. To describe the diversity and composition of the intestinal microbiota of frail individuals with respect to pre-fragile and robust individuals.
  6. To describe the body composition of frail individuals with respect to pre-fragile and robust individuals.
  7. To describe the factors associated with progression to frailty or robustness after six months of a multifactorial intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After the baseline visit, a multifactorial intervention will be carried out consisting of:

  • Distribution of short videos (10-15', in a number not exceeding 10), focused on the maintenance of a Mediterranean and balanced diet, developed by the nutrition service of our hospital. If the pandemic situation allows it, explanatory sessions will be organized with the same purpose of physical presence.
  • Distribution of short videos (10-15', in a number not exceeding 10) focused on the implementation and adherence to a progressive program of aerobic and anaerobic exercise, developed by the physiotherapy service of our hospital. If the pandemic situation allows it, explanatory sessions will be organized for the same purpose of physical presence.
  • Review of polypharmacy by the HIV Unit of our hospital.
  • Communication with the NGO Avance Positivo for the development of group socialization activities.

Study Type

Interventional

Enrollment (Estimated)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Málaga
      • Marbella, Málaga, Spain, 29603
        • Recruiting
        • Hospital Costa del Sol
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julian Olalla Sierra
        • Sub-Investigator:
          • María D Martín Escalante
        • Sub-Investigator:
          • Alfonso del Arco Jiménez
        • Sub-Investigator:
          • Pedro J Alarcón Fernández
        • Sub-Investigator:
          • José J Arenas Villafranca
        • Sub-Investigator:
          • Jimena Abiles
        • Sub-Investigator:
          • Fernando Fernández Sánchez
        • Sub-Investigator:
          • María Padilla Ruiz
        • Sub-Investigator:
          • Santiago Vico Cabra
        • Sub-Investigator:
          • Yamal Jamal-Ismail Ortiz
        • Sub-Investigator:
          • Francisco Rivas Ruiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HIV infection of at least 6 months' duration after initial diagnosis
  • Ability to sign the informed consent form
  • Stable residence in our health area

Exclusion Criteria:

  • Barthel Index<90
  • Prognosis of less than one year of life at the discretion of the investigator.
  • Inability to complete the study (8 months) as judged by the investigator or the patient
  • Presence of Child stage C cirrhosis, end-stage renal failure (Fge by CKD-EPI<10 mL/min or dialysis in any form), dementia.
  • Bone fracture within the last 3 months that interferes with gait or prehensile strength in the judgement of the investigator.
  • Diagnosis prior to inclusion in the study of diseases requiring the use of chemotherapy, radiotherapy or non-minor surgery.
  • End of chemotherapy or radiotherapy in the three months prior to study entry
  • Major surgery in the three months prior to study entry
  • Current diagnosis of wasting syndrome
  • Active neoplasm at the time of study entry, except for non-melanoma skin cancer or anal carcinoma in situ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multifactorial intervention
HIV patients
Other: Multifactorial intervention
  • Adherence to a Mediterranean diet.
  • Progressive aerobic and anaerobic exercise program.
  • Review of polypharmacy
  • Group socialization activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine change in frailty status after multifactorial intervention
Time Frame: 6 months
To assess change in frailty status: frail, pre-frail and robust; in cohort of patients before and after multifactorial intervention. It will be assessed through Fried's Phenotype which includes 5 classic criteria: slowed gait speed, poor physical activity, self-reported physical tiredness, unintentional weight loss and muscle weakness. With three or more criteria the patient will be considered as frail, 1 or 2 as pre-frail and robust in absence.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Costa del Sol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0368-N-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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