- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03102385
A Survey of Attitudes of Experienced Blood Donors
February 21, 2019 updated by: Christopher R. France, Ph.D., Ohio University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1177
Phase
- Not Applicable
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
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Ohio
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Athens, Ohio, United States, 45701
- Ohio University
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational Interview
Complete an on-line motivational interview regarding participants' blood donation experience.
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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.
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Placebo Comparator: Knowledge Interview
Complete an on-line interview regarding participants' general knowledge about blood donation.
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A web-based interview that includes open-ended questions regarding blood donation knowledge.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood donation attempts
Time Frame: 60 weeks after index donation
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The number of blood donation attempts since their study participation will be obtained from the participants' donor records.
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60 weeks after index donation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Donation Intention
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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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.
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on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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Donation Attitude
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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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.
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on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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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
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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.
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on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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Donation Subjective Norms
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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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).
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on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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Blood Donor Identity
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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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.
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on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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Blood Donation Anxiety
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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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.
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on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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Blood Donor Ambivalence
Time Frame: on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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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).
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on average 1 week after index donation; on average 2 days after interview; on average 7 weeks after interview
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Psychological Need Support
Time Frame: on average 2 days after interview
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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).
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on average 2 days after interview
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Treatment Evaluation
Time Frame: on average 2 days after interview
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Participants will be asked a series of questions regarding their experience during the interview.
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on average 2 days after interview
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
April 3, 2017
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
March 22, 2017
First Submitted That Met QC Criteria
April 4, 2017
First Posted (Actual)
April 5, 2017
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16-X-331
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified participant data may be obtained after data collection is completed.
Individual participant data requests should be directed to the Principal Investigator.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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