Blood Donor Competence, Autonomy and Relatedness Enhancement

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Donors
• Intervention / Treatment: Behavioral: Competence; Behavioral: Autonomy; Behavioral: Relatedness

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 2580
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Competence; Participants will be assigned to review our donor coping website.	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.
Experimental: Autonomy; Participants will be assigned to receive a brief telephone interview.	Behavioral: 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.
Experimental: Relatedness; Participants will be asked to join a closed Facebook group for one month.	Behavioral: 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.
Experimental: Competence + Autonomy; Participants will be assigned to the web site review, followed by the brief telephone interview.	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.; Behavioral: 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.
Experimental: Competence + Relatedness; Participants will be assigned to the web site review, followed by the one-month Facebook group membership.	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.; Behavioral: 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.
Experimental: Autonomy + Relatedness; Participants will be assigned to the brief telephone interview, followed by the one-month Facebook group membership.	Behavioral: 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.; Behavioral: 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.
Experimental: Competence + Autonomy + Relatedness; Participants will be assigned to the web site review, brief telephone interview, and one-month Facebook group membership.	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.; Behavioral: 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.; Behavioral: 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.
No Intervention: Treatment-as-Usual Control; Participants will receive the standard communications that New York Blood Center has with all first-time donors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Ohio University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); New York Blood Center
• Investigators: Principal Investigator: Christopher R. France, Ph.D., Ohio University

Publications and helpful links

General Publications

• 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.
• Frye 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.
• France 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: motivation; retention; self-determination theory; blood donor
• Other Study ID Numbers: NHLBI R01HL127766; R01HL127766 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: De-identified data will be made available one year after publication of the study findings.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)