NCT05547776

Brief Summary

The study investigators are developing and testing a mobile-friendly web-based app that contains features related to mindfulness and reducing stress for African American informal caregivers of people with chronic conditions. The purpose of the app is to help a vulnerable population reduce stress by learning and practicing mindfulness activities.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

September 16, 2022

Last Update Submit

September 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress

    Perceived stress scores entered into the app by the participant

    4 weeks

Study Arms (1)

Arms and Interventions

EXPERIMENTAL

Mindfulness App Use Participants will have the opportunity to use the mindfulness app for four weeks.

Behavioral: Mindfulness app

Interventions

Mindfulness appBEHAVIORAL

The mindfulness app contains 6 modules with a variety of features to help caregivers reduce their stress.

Arms and Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informal caregiver participants will be screened for the ability to speak English. In addition, the caregivers must currently be providing support for a person living with HIV. Support can include: 1) emotional support, 2) physical support, 3) financial support, 4) opportunities for social participation, and/or 5) health advice.

You may not qualify if:

  • Psychiatric problems such as untreated psychosis, which could preclude their ability to successfully adhere to the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Mary M Mitchell, Ph.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a feasibility trial with a single group of 30 participants who are using an app and providing feedback on the app.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

July 18, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

None formulated.

Locations