Blood DonorsPhase 3NCT02717338
Blood Donor Competence, Autonomy and Relatedness Enhancement
A Phase 3 study testing Competence, Autonomy and Relatedness in people with Blood Donors, run by Ohio University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Blood Donors
- What is being tested?
- Competence, Autonomy and Relatedness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,580 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2016to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Competence, Autonomy, Relatedness
- Keywords
- blood donor, retention, motivation, self-determination theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompetenceBehavioural
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.
AutonomyBehavioural
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.
RelatednessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Competence | Experimental | Participants will be assigned to review our donor coping website. Receives: Behavioral: Competence |
| Autonomy | Experimental | Participants will be assigned to receive a brief telephone interview. Receives: Behavioral: Autonomy |
| Relatedness | Experimental | Participants will be asked to join a closed Facebook group for one month. Receives: Behavioral: Relatedness |
| Competence + Autonomy | Experimental | Participants will be assigned to the web site review, followed by the brief telephone interview. Receives: Behavioral: Competence; Behavioral: Autonomy |
| Competence + Relatedness | Experimental | Participants will be assigned to the web site review, followed by the one-month Facebook group membership. Receives: Behavioral: Competence; Behavioral: Relatedness |
| Autonomy + Relatedness | Experimental | Participants will be assigned to the brief telephone interview, followed by the one-month Facebook group membership. Receives: Behavioral: Autonomy; Behavioral: Relatedness |
| Competence + Autonomy + Relatedness | Experimental | Participants will be assigned to the web site review, brief telephone interview, and one-month Facebook group membership. Receives: Behavioral: Competence; Behavioral: Autonomy; Behavioral: Relatedness |
| Treatment-as-Usual Control | No intervention | Participants will receive the standard communications that New York Blood Center has with all first-time donors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat Blood Donation Attempts
Donor records will be used to track all instances of subsequent donation attempts during the one-year follow-up.
Measured: one year plus 8 weeks post-initial donation
Secondary outcomes (14)
Blood Donation Attitude
Participant receives email request to complete online questionnaire at specified times.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start27 May 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Blood Center, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christopher R. France, Ph.D., Ohio University
- Investigators
- Christopher R. France, Ph.D., Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717338
- Sponsor's protocol ID
- NHLBI R01HL127766
- Other IDs
- R01HL127766
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2016
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 34224590Frye 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.
PubMed 29699961France 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.
PubMed 27979752
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Donor Competence, Autonomy and Relatedness Enhancement (Blood Donor CARE)
- ClinicalTrials.gov ID
- NCT02717338
- Acronym / sponsor ID
- NHLBI R01HL127766
- Conditions
- Blood Donors
- Keywords
- blood donor, retention, motivation, self-determination theory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,580 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- New York Blood Center, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 May 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Competence | Experimental | Behavioral: CompetenceParticipants will be assigned to review our donor coping website. |
| Autonomy | Experimental | Behavioral: AutonomyParticipants will be assigned to receive a brief telephone interview. |
| Relatedness | Experimental | Behavioral: RelatednessParticipants will be asked to join a closed Facebook group for one month. |
| Competence + Autonomy | Experimental | Behavioral: Competence, Behavioral: AutonomyParticipants will be assigned to the web site review, followed by the brief telephone interview. |
| Competence + Relatedness | Experimental | Behavioral: Competence, Behavioral: RelatednessParticipants will be assigned to the web site review, followed by the one-month Facebook group membership. |
| Autonomy + Relatedness | Experimental | Behavioral: Autonomy, Behavioral: RelatednessParticipants will be assigned to the brief telephone interview, followed by the one-month Facebook group membership. |
| Competence + Autonomy + Relatedness | Experimental | Behavioral: Competence, Behavioral: Autonomy, Behavioral: RelatednessParticipants will be assigned to the web site review, brief telephone interview, and one-month Facebook group membership. |
| Treatment-as-Usual Control | No intervention | –Participants will receive the standard communications that New York Blood Center has with all first-time donors. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CompetenceParticipants 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. | Behavioural | Competence, Competence + Autonomy, Competence + Autonomy + Relatedness, Competence + Relatedness |
| AutonomyParticipants 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. | Behavioural | Autonomy, Autonomy + Relatedness, Competence + Autonomy, Competence + Autonomy + Relatedness |
| RelatednessParticipants 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. | Behavioural | Autonomy + Relatedness, Competence + Autonomy + Relatedness, Competence + Relatedness, Relatedness |
Primary outcome
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.
14 secondary outcomes
Blood Donation Attitude
Time frame: 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)
Blood Donation Perceived Behavioral Control
Time frame: 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)
Blood Donation Personal Moral Norm
Time frame: 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)
Donation Anxiety
Time frame: 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)
Blood Donation Ambivalence Scale
Time frame: 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)
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)
Blood Donor Relatedness Scale
Time frame: 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)
Social Media Relatedness Scale
Time frame: Pre-intervention (requested 1-2 weeks post-donation) and Post-intervention (requested 7 weeks post-donation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Results publication: PubMed 34224590France 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.
- Derived from this study: PubMed 29699961Frye 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.
- Derived from this study: PubMed 27979752France 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R. France, Ph.D. principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Competence, Autonomy and Relatedness in people with Blood Donors, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeat Blood Donation Attempts (time frame: one year plus 8 weeks post-initial donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717338, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.