Frailty SyndromeHIDRA360NCT05832164
Effectiveness of a Multifactorial Intervention in Frailty Individuals With HIV Infection: HIDRA360
A study testing Multifactorial intervention in people with Frailty Syndrome and HIV Infections, run by Hospital Costa del Sol at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty Syndrome, HIV Infections
- What is being tested?
- Multifactorial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infection of at least 6 months' duration after initial diagnosis
- Ability to sign the informed consent form
- Stable residence in our health area
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Costa del Sol
Marbella, Málaga, 29603
Damaris Aguilar Ortega, 951976542, ensayos.medint.hcs.sspa@juntadeandalucia.es
Francisco A Tore Melendez, 951976620, franciscoa.tore.m.sspa@juntadeandalucia.es
About this study
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
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.
Read the 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.
- Conditions
- Frailty Syndrome, HIV Infections
- Being tested
- Multifactorial intervention
- Keywords
- Dependence, Nutrition, Physical activity, Polymedication;
- Medical subject headings
- Frailty, HIV Infections, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial interventionOther
- Adherence to a Mediterranean diet.
- Progressive aerobic and anaerobic exercise program.
- Review of polypharmacy
- Group socialization activities
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial intervention | Experimental | HIV patients Receives: Other: Multifactorial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 Dec 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Costa del Sol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Olalla Sierra, Hospital Costa del Sol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832164
- Sponsor's protocol ID
- 0368-N-22
- Acronym
- HIDRA360
- Status last verified
- Sep 2023
- First submitted
- 12 Apr 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05832164
- Acronym / sponsor ID
- HIDRA360 / 0368-N-22
- Conditions
- Frailty Syndrome, HIV Infections
- Keywords
- Dependence, Nutrition, Physical activity, Polymedication;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Hospital Costa del SolUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multifactorial intervention | Experimental | Other: Multifactorial interventionHIV patients |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infection of at least 6 months' duration after initial diagnosis
- Ability to sign the informed consent form
- Stable residence in our health area
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifactorial intervention* Adherence to a Mediterranean diet. * Progressive aerobic and anaerobic exercise program. * Review of polypharmacy * Group socialization activities | Other | Multifactorial intervention |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial intervention in people with Frailty Syndrome and HIV Infections, run by Hospital Costa del Sol at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine change in frailty status after multifactorial intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.