NCT05877391

Brief Summary

Older sexual and gender minority (SGM) patients are at risk for receiving inequitable end-of-life care; those with Alzheimer's disease and related dementias (ADRD) are at particularly high risk. Failure to collect and integrate sexual orientation and gender identity (SOGI) data to identify patients' informal support systems may have adverse health consequences for SGM older adults, particularly for those dependent on informal caregivers to provide in-home support and assist with activities of daily living. The goal of this K01 is develop a novel training for hospice staff in person-centered communication that includes SOGI data collection to promote authentic end-of-life care for SGM patients and their caregivers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Mar 2023Sep 2027

Study Start

First participant enrolled

March 13, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

4.5 years

First QC Date

March 30, 2023

Last Update Submit

June 18, 2024

Conditions

Sexual and Gender MinoritiesHospiceAlzheimer's Disease and Related Dementias

Outcome Measures

Primary Outcomes (4)

  • Barriers and facilitators to communicating with SGM older adults and perceptions and preferences for asking/disclosing SOGI

    Evaluating barriers and facilitators to creating an affirming environment where SGM patients and their caregiver feel included and safe to disclose; perceptions and preferences for asking for/disclosing SOGI.

    Years 1-2

  • Content of training

    Iteratively develop content areas with a focus on facilitating conversations with patients who are different than you.

    Years 2-3

  • Delivery of content

    Determine acceptable, replicable, and scalability of content.

    Year 3-4

  • Feasibility and assessment of training

    Evaluate feasibility of training intervention through simulation with standardized patients and hospice staff. Including evaluating content and delivery of the training and assess delivery of training, feasibility, comfort and confidence the training, incorporation into practice, and evaluation of content.

    Year 5

Secondary Outcomes (3)

  • Sources of bias and stigma

    Years 1-2

  • Ongoing engagement around SOGI-informed care

    Years 2-3

  • Accessibility

    Years 3-5

Study Arms (1)

SGM Communication Intervention

OTHER

The goal of the arm is to train hospice staff in person-centered communication that includes SOGI data collection to promote authentic end-of-life care for SGM patients and their caregivers.

Behavioral: SGM Communication Intervention

Interventions

SGM Communication InterventionBEHAVIORAL

Evaluate the feasibility and acceptability of the SGM communication intervention by hospice staff. I will pilot test the training with hospice staff to refine the content and delivery of the training. Outcomes in the pilot clinical trial will include feasibility, acceptability, and staff satisfaction with training.

SGM Communication Intervention

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • years and above

You may not qualify if:

  • People under 18, pregnant women, prisoners, and people who are decisionally challenged will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

CoitusAlzheimer Disease

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Carey Candrian, PhD

CONTACT

3037247892carey.candrian@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

May 26, 2023

Study Start

March 13, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations

US(1)