Blood Donor Competence, Autonomy and Relatedness Enhancement

Blood Donors Clinical Trial

Official title:

Blood Donor Competence, Autonomy and Relatedness Enhancement (Blood Donor CARE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717338
• Other study ID #: NHLBI R01HL127766
• Secondary ID: R01HL127766
• Status: Completed
• Phase: Phase 3
• Start date: May 27, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2022
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

For health, safety, and economic reasons there is a critical need for novel approaches to enhance the retention of new blood donors. The current study examines an innovative, theory-driven approach to retention by promoting intrinsic motivation to donate again among new blood donors. Self-determination theory (SDT) proposes that people are more likely to persist with behaviors that are internally versus externally motivated, and considerable research supports the notion that more internalized motivation is associated with better adherence in a variety of health contexts. Similar findings have also been reported in the blood donation context where measures of the extent to which a donor identity has been internalized are positively related to both donation intention and future donation behavior. Based on prior work, the investigators propose to test a multi-component intervention designed to enhance one, two, or all three of the fundamental human needs that contribute to internal motivation according to SDT (i.e., competence, autonomy, relatedness). Using a full factorial design, first-time donors will be randomly assigned to a control condition or an intervention that addresses one, two, or all three of the fundamental needs. The primary aim is to determine whether the intervention conditions, alone and in combination, increase the likelihood of a donation attempt in the next year. The second aim is to examine intervention-specific increases in competence, autonomy, and relatedness as potential mediators of enhanced donor retention. Finally, an exploratory aim will examine an integrative model of motivation that views autonomy as a mediating influence on the more proximal, situational-level determinants of behavior (i.e., attitude, subjective norm, perceived behavioral control, and intention).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2580
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Blood Donors

Intervention

Behavioral:
• Competence
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.
• Autonomy
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.
• Relatedness
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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio University	National Heart, Lung, and Blood Institute (NHLBI), New York Blood Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood Donation Attitude	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donation Subjective Norms	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donation Perceived Behavioral Control	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donation Intention	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donation Personal Moral Norm	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donation Anticipated Regret	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Donation Anxiety	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Decisional Balance Inventory for Blood Donation	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donation Ambivalence Scale	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donor Identity Survey	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donor Action and Coping Self-Efficacy	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Blood Donor Relatedness Scale	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Social Media Use Scale	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Secondary	Social Media Relatedness Scale	Participant receives email request to complete online questionnaire at specified times.	Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)