Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT06065020
Brief 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?
Detailed 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:
NCT06065020
Study Brief:
Protocol Section:
NCT06065020