Blood Donor Competence, Autonomy and Relatedness Enhancement

NCT ID: NCT02717338

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2580 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-27
• Study Completion Date: 2020-12-31

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).

Conditions

Blood Donors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Competence

Participants will be assigned to review our donor coping website.

Group Type: EXPERIMENTAL

Competence

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Autonomy

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Relatedness

Intervention Type: BEHAVIORAL

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.

Competence + Autonomy

Participants will be assigned to the web site review, followed by the brief telephone interview.

Group Type: EXPERIMENTAL

Competence

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Competence + Relatedness

Participants will be assigned to the web site review, followed by the one-month Facebook group membership.

Group Type: EXPERIMENTAL

Competence

Intervention Type: BEHAVIORAL

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.

Relatedness

Intervention Type: BEHAVIORAL

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.

Autonomy + Relatedness

Participants will be assigned to the brief telephone interview, followed by the one-month Facebook group membership.

Group Type: EXPERIMENTAL

Autonomy

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Competence + Autonomy + Relatedness

Participants will be assigned to the web site review, brief telephone interview, and one-month Facebook group membership.

Group Type: EXPERIMENTAL

Competence

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Treatment-as-Usual Control

Participants will receive the standard communications that New York Blood Center has with all first-time donors.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Blood Center

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Ohio University

OTHER

Sponsor Role: lead

Responsible Party

Christopher R. France, Ph.D.

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher R. France, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio University

Locations

Ohio University

Athens, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34224590 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29699961 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27979752 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form: Adult Consent Form

View Document

Document Type: Informed Consent Form: Child Assent Form

View Document

Document Type: Informed Consent Form: Parental Consent Form

View Document

Other Identifiers

R01HL127766

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NHLBI R01HL127766

Identifier Type: -

Identifier Source: org_study_id