Blood DonorsNCT02274064
Motivating Type O- Blood Donors to Return
A study testing Motivational Interview and Implementation Intention in people with Blood Donors, run by Ohio University at 1 site in United States.
Trial summary
This study develops a motivational interview and implementation intention intervention for blood donor retention and tests the efficacy of this new approach among first-time, Group O donors. 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 Implementation Intention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- 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
- donor with New York Blood Center or Hoxworth Blood Center
- one previous donation
- O- or O+ blood
- eligible to donate again
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study develops a motivational interview and implementation intention intervention for blood donor retention and tests the efficacy of this new approach among first-time, Group O donors.
Read the detailed description
In this study the investigators will recruit first-time Group O- and O+ donors four weeks after their donation using the donor databases of New York Blood Center and Hoxworth Blood Center. Eligible donors will be contacted via email and invited to participate in the study. Interested donors will be randomly assigned to either the Intervention condition where they will receive a motivational interview and implementation intention intervention phone call or to the Control condition where they will receive a standard donor recruitment phone call. Outcome measures will be assessed before and after the telephone contact using online questionnaires, and donation attempts will be tracked for one year. The investigators will use survival analysis to examine the effects of this intervention on retention during this one-year follow-up. Path analyses will also be used to examine potential mediators of the intervention effect. The investigators hypothesis is that donors who receive the motivational interview and implementation intention intervention will have larger increases in positive donation attitudes and perceived behavioral control which will contribute to enhanced intention and donation attempts.
- Conditions
- Blood Donors
- Being tested
- Motivational Interview and Implementation Intention
- Keywords
- Retention, Blood Donor Motivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview and Implementation IntentionBehavioural
Telephone call that includes motivational interviewing techniques and develops an implementation intention plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Donors randomly assigned to this group will receive a motivational interview and implementation intention intervention telephone call. Receives: Behavioral: Motivational Interview and Implementation Intention |
| Control | No intervention | Donors randomly assigned to this group will receive a standard donor recruitment telephone call. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat donation
number and timing of repeat donation attempts in one year following eligibility of donor return
Measured: 1 year from the date of next donor eligibility (i.e., 13 months post-intervention)
Secondary outcomes (10)
Donation attitude
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donation subjective norm
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donation perceived behavioral control
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donation intention
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donation decisional balance
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donor identity
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donation moral norm
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donation anticipated regret
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donation anxiety
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Donor self-efficacy (action and coping)
questionnaire
Measured: 1 week pre- and 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Blood Center, Hoxworth 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
- NCT02274064
- Sponsor's protocol ID
- R56HL119180
- Status last verified
- Sep 2016
- First submitted
- 21 Oct 2014
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Type O- Blood Donors to Return
- ClinicalTrials.gov ID
- NCT02274064
- Acronym / sponsor ID
- R56HL119180
- Conditions
- Blood Donors
- Keywords
- Retention, Blood Donor Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- New York Blood Center, Hoxworth Blood Center
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Oct 2014 (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.
This study develops a motivational interview and implementation intention intervention for blood donor retention and tests the efficacy of this new approach among first-time, Group O donors.
Detailed description
In this study the investigators will recruit first-time Group O- and O+ donors four weeks after their donation using the donor databases of New York Blood Center and Hoxworth Blood Center. Eligible donors will be contacted via email and invited to participate in the study. Interested donors will be randomly assigned to either the Intervention condition where they will receive a motivational interview and implementation intention intervention phone call or to the Control condition where they will receive a standard donor recruitment phone call. Outcome measures will be assessed before and after the telephone contact using online questionnaires, and donation attempts will be tracked for one year. The investigators will use survival analysis to examine the effects of this intervention on retention during this one-year follow-up. Path analyses will also be used to examine potential mediators of the intervention effect. The investigators hypothesis is that donors who receive the motivational interview and implementation intention intervention will have larger increases in positive donation attitudes and perceived behavioral control which will contribute to enhanced intention and donation attempts.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational Interview and Implementation IntentionDonors randomly assigned to this group will receive a motivational interview and implementation intention intervention telephone call. |
| Control | No intervention | –Donors randomly assigned to this group will receive a standard donor recruitment telephone call. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- donor with New York Blood Center or Hoxworth Blood Center
- one previous donation
- O- or O+ blood
- eligible to donate again
Key exclusion criteria (0 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 Interview and Implementation IntentionTelephone call that includes motivational interviewing techniques and develops an implementation intention plan. | Behavioural | Intervention |
Primary outcome
Repeat donation
Time frame: 1 year from the date of next donor eligibility (i.e., 13 months post-intervention)
number and timing of repeat donation attempts in one year following eligibility of donor return
10 secondary outcomes
Donation attitude
Time frame: 1 week pre- and 1 week post-intervention
Donation subjective norm
Time frame: 1 week pre- and 1 week post-intervention
Donation perceived behavioral control
Time frame: 1 week pre- and 1 week post-intervention
Donation intention
Time frame: 1 week pre- and 1 week post-intervention
Donation decisional balance
Time frame: 1 week pre- and 1 week post-intervention
Donor identity
Time frame: 1 week pre- and 1 week post-intervention
Donation moral norm
Time frame: 1 week pre- and 1 week post-intervention
Donation anticipated regret
Time frame: 1 week pre- and 1 week post-intervention
Donation anxiety
Time frame: 1 week pre- and 1 week post-intervention
Donor self-efficacy (action and coping)
Time frame: 1 week pre- and 1 week post-intervention
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 27 Sep 2016.
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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 Implementation Intention 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 0 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 27 Sep 2016. 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.
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 donation (time frame: 1 year from the date of next donor eligibility (i.e., 13 months post-intervention)). 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 27 Sep 2016.