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

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832164
• Other study ID #: 0368-N-22
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: September 2023
• Source: Hospital Costa del Sol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: January 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Frailty
• Frailty Syndrome
• HIV Infections
• Infections

Intervention

Other:
• Multifactorial intervention
Adherence to a Mediterranean diet. Progressive aerobic and anaerobic exercise program. Review of polypharmacy Group socialization activities

Locations

Country	Name	City	State
Spain	Hospital Costa del Sol	Marbella	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Costa del Sol

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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