Community Intervention to Improve Depressive Symptoms Among Older Adults

Status Recruiting

Clinical Trial Summary

The goal of this pilot trial is to test how feasible is to conduct a large clinical trial that evaluate both implementation and effectiveness outcomes of a community-based interventions for older adults with depression in low-resource urban settings from Lima, Peru. The main questions: Is the way we are planning the study, including those who are taking part and what they will do, good for a large study? Is the interventional package we are developing good the way it is, and can it be done the way we planned it?

Clinical Trial Description

Participants who join will be split into two groups: one group will get the interventional program, and the other group will get standard care. In the interventional group, community health workers will meet with participants eight times to do activities and talk about how they feel. The standard group will have two visits where they will learn things about mental health. The results of the study will help the researchers understand whether they can test the program in larger study. Additionally, see whether those participants in the interventional group feel better than those who are in the standard group. Sample size: This is a pilot trial. No sample size calculations are needed because the objective is NOT to evaluate the effect of the intervention, but rather the feasibility of conducting a large-scale clinical trial. It is expected to enroll 64 participants (32 control group vs 32 intervention group). This number is based on previous formative study and training of community health workers. Researchers will collect basic information to assess feasibility for a larger trial, including: - Number of potential participants screened per month; - Number of participants enroled per month; - Average time from enrolment to randomisation. - Average time to reach enrolment goal - Proportion of eligible participants who enrol - Proportion of people who maintain the study in both groups. - Reasons for abandoning the study. - Visit durations ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06065020
Study type	Interventional
Source	Universidad de San Martín de Porres
Contact	Oscar Flores-Flores, MD, MSc
Phone	+51934901717
Email	ofloresf@usmp.pe
Status	Recruiting
Phase	N/A
Start date	October 23, 2023
Completion date	December 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA) — VIDACTIVA1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms