Blood Donor Competence, Autonomy and Relatedness Enhancement
2 other identifiers
interventional
2,580
1 country
1
Brief Summary
The purpose of this study is to determine whether enhancing blood donor competence, autonomy, and/or relatedness increases intrinsic motivation to donate and improves donor retention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2016
Longer than P75 for phase_3
1 active site
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
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedStudy Start
First participant enrolled
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 3, 2022
February 1, 2022
4.6 years
February 18, 2016
February 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Repeat Blood Donation Attempts
Donor records will be used to track all instances of subsequent donation attempts during the one-year follow-up.
one year plus 8 weeks post-initial donation
Secondary Outcomes (14)
Blood Donation Attitude
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Blood Donation Subjective Norms
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Blood Donation Perceived Behavioral Control
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Blood Donation Intention
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Blood Donation Personal Moral Norm
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
- +9 more secondary outcomes
Study Arms (8)
Competence
EXPERIMENTALParticipants will be assigned to review our donor coping website.
Autonomy
EXPERIMENTALParticipants will be assigned to receive a brief telephone interview.
Relatedness
EXPERIMENTALParticipants will be asked to join a closed Facebook group for one month.
Competence + Autonomy
EXPERIMENTALParticipants will be assigned to the web site review, followed by the brief telephone interview.
Competence + Relatedness
EXPERIMENTALParticipants will be assigned to the web site review, followed by the one-month Facebook group membership.
Autonomy + Relatedness
EXPERIMENTALParticipants will be assigned to the brief telephone interview, followed by the one-month Facebook group membership.
Competence + Autonomy + Relatedness
EXPERIMENTALParticipants will be assigned to the web site review, brief telephone interview, and one-month Facebook group membership.
Treatment-as-Usual Control
NO INTERVENTIONParticipants will receive the standard communications that New York Blood Center has with all first-time donors.
Interventions
Participants will be assigned to review our donor coping website that combines text, videos, and interactive features to directly address common donor fears and to offer advice on empirically-validated strategies to reduce fear, pain, and syncopal reactions.
Participants will be assigned to receive a brief telephone interview that we have developed that encourages blood donors to reflect upon their unique motivations for giving and how the act of donating is consistent with their broader life goals and values.
Participants will be asked to join a closed Facebook group for one month. The group encourages participants to discuss their experiences with blood donation, including such things as posting images of their donations and/or reasons for donating. Posts will be designed to encourage social interaction around donation experiences, identity formation and group affiliation.
Eligibility Criteria
You may qualify if:
- First-time whole blood donor with New York Blood Center;
- Eligible to donate again;
- Willing to be randomly assigned;
- Have, or be willing to establish, an active Facebook account.
You may not qualify if:
- History of more than one lifetime whole blood donation (with any blood center);
- Ineligible to donate again (based on New York Blood Center donor eligibility determination);
- Unwilling to be randomly assigned;
- Unwilling to sign up for closed Facebook group, if randomly assigned.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio Universitylead
- New York Blood Centercollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Ohio University
Athens, Ohio, 45701, United States
Related Publications (3)
France CR, France JL, Himawan LK, Fox KR, Livitz IE, Ankawi B, Slepian PM, Kowalsky JM, Duffy L, Kessler DA, Rebosa M, Rehmani S, Frye V, Shaz BH. Results from the blood donor competence, autonomy, and relatedness enhancement (blood donor CARE) randomized trial. Transfusion. 2021 Sep;61(9):2637-2649. doi: 10.1111/trf.16577. Epub 2021 Jul 5.
PMID: 34224590RESULTFrye V, Duffy L, France JL, Kessler DA, Rebosa M, Shaz BH, Carlson BW, France CR. The Development of a Social Networking-Based Relatedness Intervention Among Young, First-Time Blood Donors: Pilot Study. JMIR Public Health Surveill. 2018 Apr 26;4(2):e44. doi: 10.2196/publichealth.8972.
PMID: 29699961DERIVEDFrance CR, France JL, Carlson BW, Frye V, Duffy L, Kessler DA, Rebosa M, Shaz BH. Applying self-determination theory to the blood donation context: The blood donor competence, autonomy, and relatedness enhancement (Blood Donor CARE) trial. Contemp Clin Trials. 2017 Feb;53:44-51. doi: 10.1016/j.cct.2016.12.010. Epub 2016 Dec 12.
PMID: 27979752DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher R. France, Ph.D.
Ohio University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
February 18, 2016
First Posted
March 23, 2016
Study Start
May 27, 2016
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 3, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- De-identified data will be made available one year after publication of the study findings.
- Access Criteria
- A controlled access approach will be used to share de-identified data with individuals who 1) make an official request to the Principal Investigator, 2) demonstrate a legitimate academic purpose for the request, 3) provide evidence of up-to-date compliance with human subjects ethics training, and 4) agree to delete the data within an agreed-upon timeframe and not share the data with others.
Following publication of our findings, the raw and processed data will be freely available to any researcher who requests a copy. The raw data files will be stored as EXCEL and SPSS data files and will be de-identified so there is no possibility of connecting the information with the original participants. To obtain access to the data, interested parties can contact the PI.