ClinicalTrials.gov
ClinicalTrials.gov Menu

Blood Donor Competence, Autonomy and Relatedness Enhancement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02717338
Recruitment Status : Enrolling by invitation
First Posted : March 23, 2016
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
New York Blood Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Christopher R. France, Ph.D., Ohio University

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.

Condition or disease Intervention/treatment Phase
Blood Donors Behavioral: Competence Behavioral: Autonomy Behavioral: Relatedness Phase 3

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  (Clinical Trial)
Estimated Enrollment : 2240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blood Donor Competence, Autonomy and Relatedness Enhancement (Blood Donor CARE)
Actual Study Start Date : May 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Repeat Blood Donation Attempts [ Time Frame: one year plus 8 weeks post-initial donation ]
    Donor records will be used to track all instances of subsequent donation attempts during the one-year follow-up.


Secondary Outcome Measures :
  1. Blood Donation Attitude [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  2. Blood Donation Subjective Norms [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  3. Blood Donation Perceived Behavioral Control [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  4. Blood Donation Intention [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  5. Blood Donation Personal Moral Norm [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  6. Blood Donation Anticipated Regret [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  7. Donation Anxiety [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  8. Decisional Balance Inventory for Blood Donation [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  9. Blood Donation Ambivalence Scale [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  10. Blood Donor Identity Survey [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  11. Blood Donor Action and Coping Self-Efficacy [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  12. Blood Donor Relatedness Scale [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  13. Social Media Use Scale [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.

  14. Social Media Relatedness Scale [ Time Frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation) ]
    Participant receives email request to complete online questionnaire at specified times.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717338


Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
New York Blood Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Christopher R. France, Ph.D. Ohio University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher R. France, Ph.D., Distinguished Professor, Ohio University
ClinicalTrials.gov Identifier: NCT02717338     History of Changes
Other Study ID Numbers: NHLBI R01HL127766
R01HL127766 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (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.

Keywords provided by Christopher R. France, Ph.D., Ohio University:
blood donor
retention
motivation
self-determination theory