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

Primary Purpose

Frailty Syndrome, HIV Infections

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multifactorial intervention
Sponsored by
Hospital Costa del Sol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty Syndrome focused on measuring Dependence, Nutrition, Physical activity, Polymedication;

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Costa del SolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multifactorial intervention

Arm Description

HIV patients

Outcomes

Primary Outcome Measures

Determine change in frailty status after multifactorial intervention
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.

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
September 4, 2023
Sponsor
Hospital Costa del Sol
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1. Study Identification

Unique Protocol Identification Number
NCT05832164
Brief Title
Effectiveness of a Multifactorial Intervention in Frailty Individuals With HIV Infection: HIDRA360
Acronym
HIDRA360
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Costa del Sol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty Syndrome, HIV Infections
Keywords
Dependence, Nutrition, Physical activity, Polymedication;

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study design consists of two stages: a descriptive cross-sectional study to assess the prevalence of frailty in a cohort of HIV patients and, subsequently, a quasi-experimental before/after study without equivalent control group to evaluate the effectiveness of a multifactorial intervention. The intervention will be offered to all patients, regardless of their frailty, pre-frailty or robustness status.
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multifactorial intervention
Arm Type
Experimental
Arm Description
HIV patients
Intervention Type
Other
Intervention Name(s)
Multifactorial intervention
Intervention Description
Adherence to a Mediterranean diet. Progressive aerobic and anaerobic exercise program. Review of polypharmacy Group socialization activities
Primary Outcome Measure Information:
Title
Determine change in frailty status after multifactorial intervention
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damaris Aguilar Ortega
Phone
951976542
Email
ensayos.medint.hcs.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Francisco A Tore Melendez
Phone
951976620
Email
franciscoa.tore.m.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Julian Olalla Sierra
First Name & Middle Initial & Last Name & Degree
María D Martín Escalante
First Name & Middle Initial & Last Name & Degree
Alfonso del Arco Jiménez
First Name & Middle Initial & Last Name & Degree
Pedro J Alarcón Fernández
First Name & Middle Initial & Last Name & Degree
José J Arenas Villafranca
First Name & Middle Initial & Last Name & Degree
Jimena Abiles
First Name & Middle Initial & Last Name & Degree
Fernando Fernández Sánchez
First Name & Middle Initial & Last Name & Degree
María Padilla Ruiz
First Name & Middle Initial & Last Name & Degree
Santiago Vico Cabra
First Name & Middle Initial & Last Name & Degree
Yamal Jamal-Ismail Ortiz
First Name & Middle Initial & Last Name & Degree
Francisco Rivas Ruiz

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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