Clinical trial NCT06743685: Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women
Official title: A Pilot Feasibility Trial of HEALthy Beginnings: A Trauma-Informed, Chronic Disease Self-Care Intervention for Middle-Aged, and Older Homeless Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Homelessness
Health Promotion
Chronic Disease Self-care
Multimorbidity
Unhoused
Keywords: Middle-aged and older
People experiencing homelessness
Women
Elderly
Trauma-informed care
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Hillman Foundation
First posted: 2024-12-20
Enrollment: 23
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment as a measure of feasibility of the HEALthy Beginnings intervention
timeFrame: Day 1
measure: Completion as a measure of feasibility of the HEALthy Beginnings intervention
timeFrame: Upon completion of all group and individual sessions, approximately 12 Weeks
Secondary outcomes:
measure: Participant evaluation of HEALthy beginnings intervention
timeFrame: Upon completion of all group and individual sessions, approximately 12 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Downtown Women's Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Benissa E. Salem, PhD, MSN, RN, CNL, PHN
role: PRINCIPAL_INVESTIGATOR
References: