NCT06359392

Brief Summary

The investigators will be conducting a randomized trial in 3 reservation communities to test the efficacy of the narrative as culture-centric health promotion model for increasing American Indian tribal members' palliative care knowledge and intentions to discuss palliative care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 29, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

April 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

March 29, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

palliative careAmerican Indianhospiceend of life

Outcome Measures

Primary Outcomes (5)

  • Palliative Care Knowledge Scale (PaCKS)

    The 13-item PaCKS measures palliative care knowledge among lay people, using true/false items covering topics like goals of palliative care. We know palliative care awareness is lacking; thus it is important to understand knowledge gaps; hence we will modify the response options to include "I don't know" in addition to true/false.

    2 hours

  • Knowledge of Care Options (KOCO)

    The 11-item KOCO measures gaps in knowledge of care options among cancer patients for curative, palliative, and hospice care using true-false options.

    2 hours

  • Hospice and Palliative Care Questionnaire (HPCQ)

    The 12-item HPCQ examines attitudes, use, and interest in receiving more information. There are 6 hospice and 6 palliative care questions, that have been used successfully with ethnically diverse populations.

    2 hours

  • Identification and Transportation with Palliative Care Message

    Individuals watching either the culture-centric palliative care video or the general video will be asked to ask 5 questions about emotions they felt, how they identified with the main characters in the video, and how focused they were while watching the video

    2 hours

  • Attitudes and Intentions to Discuss Palliative Care

    Those watching the culture-centric video or the general message video will be asked to respond to 5 questions about their intentions to discuss pallative care with their family.

    2 hours

Study Arms (3)

No Message

OTHER

Individuals assigned to this arm will take the surveys only and not be exposed to a palliative care message.

Other: No message

Culture-centric message

OTHER

Individuals assigned to this arm will watch a 2 minute culture-centric palliative care video specific for these American Indian communities and then take the surveys after watching the videos.

Other: Culture-centric message

General message

OTHER

Individuals assigned to this arm will watch a 2 minute palliative care video created for the general US population and then take the surveys after watching the videos.

Other: General messge

Interventions

Participants will not be exposed to a message in this arm of the intervention.

No Message

Participants in this arm of the study will watch a 2-minute video on palliative care developed specifically for these American Indian communities.

Culture-centric message

Participants receiving this intervention will watch a 2-minute video developed by the National Hospice and Palliative Care Organization to teach about palliative care.

General message

Eligibility Criteria

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

You may qualify if:

  • years old or older
  • Self-identify as American Indian
  • Must be able to read and comprehend English
  • Live on or around the Pine Ridge Indian Reservation, Rosebud Indian Reservation, or Cheyenne River Indian Reservation

You may not qualify if:

  • Under the age of 18 years
  • Not American Indian
  • Do not live near or on the Pine Ridge Indian Reservation, Rosebud Indian Reservation, or Cheyenne River Indian Reservation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Dakota State University

Rapid City, South Dakota, 57701, United States

Location

MeSH Terms

Conditions

BehaviorDeath

Interventions

NMT1 protein, S pombe

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mary J Isaacson, PhD, RN

    South Dakota State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 11, 2024

Study Start

April 29, 2024

Primary Completion

June 13, 2024

Study Completion

June 13, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

We are working with Tribal communities that are sovereign nations and we will share their data back with them at the end of the trial. We have to obtain special permission in order to share de-identified data more broadly.

Locations