Blood Donor Competence, Autonomy and Relatedness Enhancement

February 15, 2022 updated by: Christopher R. France, Ph.D., Ohio University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2580

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 20 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one year plus 8 weeks post-initial donation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
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.
Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
New York Blood Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher R. France, Ph.D., Ohio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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