Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women

NCT ID: NCT06743685

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2025-12-31

Brief Summary

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This is a mixed methods pilot feasibility trial of HEALthy Beginnings, an innovative, nurse-driven intervention. Middle-aged and older, homeless women (MAO-HW) will participate in the HEALthy Beginnings intervention and select MAO-HW will be invited to participate in post-intervention qualitative focus groups to evaluate the program.

Detailed Description

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This pilot feasibility trial will enroll middle-aged and older, homeless women (MAO-HW) in the HEALthy Beginnings intervention. Participants will be asked to complete a baseline questionnaire and locator guide. Participants will then engage over a period of approximately three months in nine 60-90 minute group sessions focused on health topics, and to meet with a research team member for six private sessions which will last up to 45 minutes each to assess the program and discuss content.

Fifteen participants will be asked to return at completion of the group/individual sessions to participate in a post-intervention qualitative focus group and follow-up questionnaire to evaluate the HEALthy Beginnings intervention.

Conditions

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Homelessness Health Promotion Chronic Disease Self-care Multimorbidity Unhoused

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All eligible participants will be invited to enroll in the HEALthy Beginnings intervention, a trauma-informed, chronic disease self-care intervention for middle-aged, and older homeless women. Participants will attend nine group sessions and six individual sessions over approximately 12 weeks. A subset of participants will be invited to participate in post-intervention focus groups as well as to complete a questionnaire evaluating the HEALthy Beginnings intervention.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HEALthy Beginnings Intervention group

Middle-aged, and older, homeless women (MAO-HW) participating in the HEALthy Beginnings Intervention

Group Type EXPERIMENTAL

HEALthy Beginnings

Intervention Type BEHAVIORAL

HEALthy Beginnings, an innovative, enhanced, trauma-informed, chronic disease self-care program and nurse-driven intervention, developed and tailored for middle-aged, and older, homeless women (MAO-HW).

Interventions

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HEALthy Beginnings

HEALthy Beginnings, an innovative, enhanced, trauma-informed, chronic disease self-care program and nurse-driven intervention, developed and tailored for middle-aged, and older, homeless women (MAO-HW).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-reported age 40 years or older
* Sex assigned Female at birth
* Homeless, or living in a shelter designed to provide transitional housing
* Self-reported multimorbidity (at least 2 physical/mental health conditions)
* Able to communicate in English

Exclusion Criteria

* Experiencing hallucinations
* Exhibiting signs of acute intoxication (e.g., slurred speech, pin-point pupils, difficulty walking)
* Non-English speaking
* Unable to understand study procedures (e.g., screening questions)
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hillman Foundation

UNKNOWN

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Benissa E. Salem

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benissa E. Salem, PhD, MSN, RN, CNL, PHN

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Downtown Women's Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Benissa E. Salem, PhD, MSN, RN, CNL, PHN

Role: CONTACT

310-948-4881

Other Identifiers

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85834

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-001117

Identifier Type: -

Identifier Source: org_study_id

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