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

NCT05832164 | Unknown DMC

• 1 other identifier: 0368-N-22
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Frailty Syndrome; HIV Infections

Keywords

Dependence; Nutrition; Physical activity; Polymedication;

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

Multifactorial intervention

EXPERIMENTAL

HIV patients

Other: Multifactorial intervention

Interventions

Multifactorial intervention OTHER

* Adherence to a Mediterranean diet. * Progressive aerobic and anaerobic exercise program. * Review of polypharmacy * Group socialization activities

Multifactorial intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Hospital Costa del Sol: lead

Study Sites (1)

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

RECRUITING

MeSH Terms

Conditions

Frailty; HIV Infections; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Specialist, Department of Internal Medicine, Hospital Costa del Sol, Marbella (Malaga,) Spain

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 27, 2023
• Study Start: December 15, 2022
• Primary Completion: October 31, 2023
• Study Completion: January 31, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)