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:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03304535
Brief Summary:
The purpose of this research study is to determine whether involvement with a social worker helps reduce distress, depression, and increase patient activation in participants over a 6 month intervention period. The study will also describe common barriers to care that participants face.
Detailed Description:
An appointment will be scheduled for participant to meet with a social worker. The appointment may happen on day of participant's scheduled clinic appointment or on another mutually decided upon date and time. Should participant choose to participate, this first visit will be Visit 1 for the study.
Visit 1: Baseline
Informed consent will be obtained demonstrating an interest in participating.
A visit with the social worker will take place during Visit 1. This session will be held in a private office and allows participant time for discussion regarding any challenges, struggles and/or barriers they may be experiencing.
The following baseline questionnaires/surveys will be administered:
Modified Patient Activation Measure - measures participant confidence in taking care of their own health.
Distress Thermometer - measures participant distress level during the past week.
Patient Health Questionnaire -measures depression symptoms and severity if any.
Clinical information will be taken from participant's medical record. There may be follow-up questions related to data if information is unclear or incomplete.
Upon completion of Visit 1, participant will receive a satisfaction survey to evaluate how participant satisfaction with social worker interaction.
Social Worker Interventions: After Visit 1 and before Visit 2
The social worker will develop an intervention for participant during Visit 1 appointment. As many calls or in person meetings participant requires will take place. There will be no limit and it will be determined by participant's needs.
Visit 2: Follow-up After 6 Months
Upon completion of participant's six month follow-up in the study, the following questionnaires/surveys will be administered:
Modified Patient Activation Measure - measures how confident participant is at taking care of their own health.
Distress Thermometer - measures how much distress participant has been experiencing in the past week.
Patient Health Questionnaire - measures if participant has symptoms of depression and the severity of those symptoms.
Satisfaction Survey - measures how satisfied participant is with the social worker interaction.
Study:
NCT03304535
Study Brief:
Protocol Section:
NCT03304535