Blood DonorsNCT03102385
A Survey of Attitudes of Experienced Blood Donors
A study testing Motivational Interview and Knowledge Interview in people with Blood Donors, run by Ohio University at 1 site in United States.
Trial summary
This study examines the effects of a web-based motivational interview on 1) internal motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation intention and behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Donors
- What is being tested?
- Motivational Interview and Knowledge Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,177 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 1 Nov 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject donated blood within the last week with New York Blood Center.
- Subject has made 2 or more blood donations.
- Subject is eligible to donate blood again.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the effects of a web-based motivational interview on 1) internal motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation intention and behavior. The study also evaluates whether group differences in donation intention and behavior are mediated by autonomy, competence, and relatedness, and in turn, internal motivation.
Read the detailed description
Voluntary blood donation is both important and necessary for the provision of a steady and safe blood supply. With an aging population and increased restrictions on who can donate blood, maintenance of a stable blood supply is essential. Although 38% of the United States population is eligible to donate, only 5% actually does so. Retention of donors is essential to assuring the continuity of a safe blood supply; repeat donors are safer, more cost effective, and less likely to experience adverse reactions. Current recruitment and retention methods may not be sufficient to encourage repeat donations. According to Self-Determination Theory, people are more likely to persist with behaviors that are internally versus externally motivated. Internal motivation is enhanced by supporting an individual's needs for autonomy, competence, and relatedness. One intervention that has shown early promise as a novel method to enhance internal motivation to donate blood is motivational interviewing. However, implementation of a motivational interviewing intervention is costly and time consuming. Given the time and money required for training and delivery of a motivational interviewing intervention, the current study is designed to test the efficacy of a newly-developed web-based version of a motivational interview. Participants will be randomly assigned to complete either an on-line motivational interview about their blood donation experience or an on-line knowledge interview about blood donation.
- Conditions
- Blood Donors
- Being tested
- Motivational Interview, Knowledge Interview
- Keywords
- blood donation, motivation, donor retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewBehavioural
A web-based computer-tailored intervention that includes open-ended questions, reflective responses, affirmations, and summarizing, as well as informing and advising. Specific topics include 1) individual motivations for giving, 2) the relationship between past donation behavior and the individual's personal goals/values, 3) donation importance and confidence rulers, 4) addressing donor concerns, and 5) summarizing.
Knowledge InterviewBehavioural
A web-based interview that includes open-ended questions regarding blood donation knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Experimental | Complete an on-line motivational interview regarding participants' blood donation experience. Receives: Behavioral: Motivational Interview |
| Knowledge Interview | Placebo comparator | Complete an on-line interview regarding participants' general knowledge about blood donation. Receives: Behavioral: Knowledge Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood donation attempts
The number of blood donation attempts since their study participation will be obtained from the participants' donor records.
Measured: 60 weeks after index donation
Secondary outcomes (9)
Donation Intention
Intent to donate blood within the next 8 weeks will be assessed using three questions on a 7-point Likert-type scale, from 1 (disagree) to 7 (agree): I plan to donate blood in the next 8 weeks., How likely is it that you will donate blood in the next 8 weeks? and I will donate blood in the next 8 weeks. Total scores on the scale range from 3 to 21, with higher scores indicating greater intention to donate.
Measured: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Attitude
Attitudes toward blood donation will be assessed using a 6-item measure where individuals are asked to rate how donating blood in the next 8 weeks would seem using a 7-item Likert-type scale. The scale distinguishes between cognitive attitudes (evaluative judgments: useful versus useless, pointless versus worthwhile, the wrong thing to do versus the right thing to do) and affective attitudes (emotional reactions: unpleasant versus pleasant, unenjoyable versus enjoyable, frightening versus not frightening). Total scores on the scale range from 6 to 42, with higher scores reflecting more positive attitudes toward blood donation.
Measured: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Perceived Behavioral Control
Individuals' perception of control over their ability to donate blood will be assessed using a 6-item measure that assesses two components of perceived behavioral control: self-efficacy (three items) and controllability (three items). Items on the self-efficacy sub-scale ask about how confident the participant is in their ability to donate blood in the next 8 weeks, while the controllability sub-scale assesses how much control participants feel they have over whether or not they donate blood. Participants are asked to rate each item on a 7-point Likert-type scale. Total scores on the scale range from 6 to 42, with higher scores reflecting greater perception of control over ones ability to donate blood.
Measured: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Subjective Norms
Individuals' perception about subjective norms will be assessed using a six item, 7-point Likert-type scale, with anchors at 1 (disagree/unlikely) and 7 (agree/likely). Total scores on the scale range from 6 to 42. The measure assesses both descriptive norms (perceived behavior of others) and injunctive norms (what an individual believes others want from him/her).
Measured: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donor Identity
Blood Donor Identity will be measured using an 18-item scale that examines an individual's motivation to donate on the six motivational factors proposed by Self Determination Theory: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation. Participants are asked to rate their agreement with each item on a 7-point Likert-type scale, with individual item scores ranging from 1 (not at all true) to 7 (very true). A composite score for the total scale is calculated by combining the six subscale scores using the weighting of -3, -2, -1, +1, +2, +3 for the amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic regulation subscales, respectively, in order to produce a single Relative Autonomy Index score.
Measured: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donation Anxiety
Anxiety will be assessed using the Blood Donor Anxiety Scale, a six-item scale that assesses for both the presence (3 items) and absence (3 items) of anxiety. Participants rate their agreement on how relaxed, content, pleasant, tense, nervous and jittery they would feel if they donated blood on a 4-point scale, with anchors at 1 (not at all) and 4 (very much). Composite scores on the scale range from 3 to 12, with higher scores on the presence subscale reflecting more anxiety, and higher scores on the absence subscale reflecting less anxiety about a future donation.
Measured: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donor Ambivalence
The 6-item ambivalence scale asks participants to rate how true a statement is for them on a 7-point scale (1=Not at all true to 7=Very true). Separate subscale scores are calculated for commitment and indecision (scores ranging from 3 to 21 for each subscale).
Measured: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Psychological Need Support
To assess whether the Motivational Interview intervention supported the basic psychological needs of autonomy, competence, and relatedness, a 9-item Likert-type scale will be utilized (3 items per psychological need, anchors at 1 = Not at All and 7 = Extremely).
Measured: on average 2 days after interview
Treatment Evaluation
Participants will be asked a series of questions regarding their experience during the interview.
Measured: on average 2 days after interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start3 Apr 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either (1) complete an on-line motivational interview about their blood donation experience, or (2) complete an on-line knowledge interview about blood donation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Blood Center
- Responsible party
- Principal investigator, Christopher R. France, Ph.D., Ohio University
- Investigators
- Christopher R France, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102385
- Sponsor's protocol ID
- 16-X-331
- Status last verified
- Feb 2019
- First submitted
- 22 Mar 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data may be obtained after data collection is completed. Individual participant data requests should be directed to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Attitudes of Experienced Blood Donors
- ClinicalTrials.gov ID
- NCT03102385
- Acronym / sponsor ID
- 16-X-331
- Conditions
- Blood Donors
- Keywords
- blood donation, motivation, donor retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- New York Blood Center
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
This study examines the effects of a web-based motivational interview on 1) internal motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation intention and behavior. The study also evaluates whether group differences in donation intention and behavior are mediated by autonomy, competence, and relatedness, and in turn, internal motivation.
Detailed description
Voluntary blood donation is both important and necessary for the provision of a steady and safe blood supply. With an aging population and increased restrictions on who can donate blood, maintenance of a stable blood supply is essential. Although 38% of the United States population is eligible to donate, only 5% actually does so. Retention of donors is essential to assuring the continuity of a safe blood supply; repeat donors are safer, more cost effective, and less likely to experience adverse reactions. Current recruitment and retention methods may not be sufficient to encourage repeat donations. According to Self-Determination Theory, people are more likely to persist with behaviors that are internally versus externally motivated. Internal motivation is enhanced by supporting an individual's needs for autonomy, competence, and relatedness. One intervention that has shown early promise as a novel method to enhance internal motivation to donate blood is motivational interviewing. However, implementation of a motivational interviewing intervention is costly and time consuming. Given the time and money required for training and delivery of a motivational interviewing intervention, the current study is designed to test the efficacy of a newly-developed web-based version of a motivational interview. Participants will be randomly assigned to complete either an on-line motivational interview about their blood donation experience or an on-line knowledge interview about blood donation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either (1) complete an on-line motivational interview about their blood donation experience, or (2) complete an on-line knowledge interview about blood donation.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Experimental | Behavioral: Motivational InterviewComplete an on-line motivational interview regarding participants' blood donation experience. |
| Knowledge Interview | Placebo comparator | Behavioral: Knowledge InterviewComplete an on-line interview regarding participants' general knowledge about blood donation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject donated blood within the last week with New York Blood Center.
- Subject has made 2 or more blood donations.
- Subject is eligible to donate blood again.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Motivational InterviewA web-based computer-tailored intervention that includes open-ended questions, reflective responses, affirmations, and summarizing, as well as informing and advising. Specific topics include 1) individual motivations for giving, 2) the relationship between past donation behavior and the individual's personal goals/values, 3) donation importance and confidence rulers, 4) addressing donor concerns, and 5) summarizing. | Behavioural | Motivational Interview |
| Knowledge InterviewA web-based interview that includes open-ended questions regarding blood donation knowledge. | Behavioural | Knowledge Interview |
Primary outcome
Blood donation attempts
Time frame: 60 weeks after index donation
The number of blood donation attempts since their study participation will be obtained from the participants' donor records.
9 secondary outcomes
Donation Intention
Time frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Attitude
Time frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Perceived Behavioral Control
Time frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Donation Subjective Norms
Time frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donor Identity
Time frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donation Anxiety
Time frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Blood Donor Ambivalence
Time frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
Psychological Need Support
Time frame: on average 2 days after interview
Treatment Evaluation
Time frame: on average 2 days after interview
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 25 Feb 2019.
- Individual participant dataSharing planned: Yes. De-identified participant data may be obtained after data collection is completed. Individual participant data requests should be directed to the Principal Investigator.
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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, PhD 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 study testing Motivational Interview and Knowledge Interview 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 3 inclusion and 1 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 25 Feb 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Blood donation attempts (time frame: 60 weeks after index donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2019.