Clinical trial NCT02717338: Blood Donor Competence, Autonomy and Relatedness Enhancement
Official title: Blood Donor Competence, Autonomy and Relatedness Enhancement (Blood Donor CARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Donors
Keywords: blood donor
retention
motivation
self-determination theory
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: New York Blood Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-03-23
Enrollment: 2580
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Repeat Blood Donation Attempts
timeFrame: one year plus 8 weeks post-initial donation
Secondary outcomes:
measure: Blood Donation Attitude
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donation Subjective Norms
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donation Perceived Behavioral Control
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donation Intention
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donation Personal Moral Norm
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donation Anticipated Regret
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Donation Anxiety
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Decisional Balance Inventory for Blood Donation
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donation Ambivalence Scale
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donor Identity Survey
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donor Action and Coping Self-Efficacy
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Blood Donor Relatedness Scale
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Social Media Use Scale
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
measure: Social Media Relatedness Scale
timeFrame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: Christopher R. France, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.