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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06359392
Other study ID # DNZNC466DGR7
Secondary ID 1R21NR020383-01
Status Recruiting
Phase N/A
First received
Last updated
Start date April 29, 2024
Est. completion date May 15, 2024

Study information

Verified date May 2024
Source South Dakota State University
Contact Mary J Isaacson, PhD, RN, RHNC, CHPN, FPCN
Phone 605-670-0975
Email mary.isaacson@sdstate.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Palliative care is specialized patient-/family-centered care designed to reduce suffering and enhance quality of life for persons with serious illness. Culturally responsive palliative care can ease serious illness burden experienced by American Indians (AIs) and improve seriously ill AIs end-of-life decision-making. However, for seriously ill Northern Plains AIs, specifically those in South Dakota (SD), access to and use of culturally responsive palliative care is severely limited. To address this need, the investigators have formed a multidisciplinary, tribally-driven collaborative team consisting of Great Plains Tribal Leaders Health Board, active AI community advisory boards at the following reservations: Cheyenne River, Rosebud, and Pine Ridge, and South Dakota State University. The research team will conduct a campaign messaging efficacy test using the narrative as culture-centric health promotion model (NCHP) to create and test culture-centric narrative messaging that improves knowledge of palliative care and encourages participants to engage in formal and informal communication about palliative care. The NCHP model is an evidence-based innovative approach to enhance AI's knowledge and intentions to talk formally and informally about palliative care, because it provides guidelines for how to construct culture-centric narratives which identify the features of effective narratives and the mechanisms by which the narratives work to transform cognitive and behavioral outcomes. The investigators have developed a culture-centric narrative health video message and will be conducting a randomized trial to test the efficacy of the NCHP model for increasing AI tribal members' palliative care knowledge and intentions to discuss palliative care.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date May 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No message
Participants will not be exposed to a message in this arm of the intervention.
Culture-centric message
Participants in this arm of the study will watch a 2-minute video on palliative care developed specifically for these American Indian communities.
General messge
Participants receiving this intervention will watch a 2-minute video developed by the National Hospice and Palliative Care Organization to teach about palliative care.

Locations

Country Name City State
United States South Dakota State University Rapid City South Dakota

Sponsors (3)

Lead Sponsor Collaborator
South Dakota State University Great Plains Tribal Leaders Health Board, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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