Lipid Metabolism DisorderDONATE-FHNCT05693701
Multicomponent Intervention Study- Blood Donors With High Cholesterol
A study testing Implementation Strategy Bundle in people with Lipid Metabolism Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lipid Metabolism Disorder
- What is being tested?
- Implementation Strategy Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria
- Age 18 to 75 years
Who cannot join
- Currently taking medication to lower cholesterol
- Taking any medication that can interact with statins
- Pregnancy
- Identified secondary cause of elevated lipids
- Chronic liver disease or significantly elevated liver function tests (> 3 times upper limit)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Lakeisha Cade, 214.648.2878, BloodDonorStudy@UTSouthwestern.edu
Amit Khera, MD, BloodDonorStudy@UTSouthwestern.edu
About this study
Official title: Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
Read the detailed description
This is a single center randomized, two arm trial. The two study arms include usual care (standard notification) and implementation bundle intervention. UT Southwestern Medical Center will be the main study site and Carter Blood Care will serve as the recruitment site.
Screening/Baseline visit: Donors agreeing to participate in the study will be informed of study procedures and will provide informed consent. A 20 mL blood sample as well as a urine sample will be obtained for eligibility screening laboratories and baseline LDL-C.
Follow-up phone call: At 3 months post-randomization, participants in both arms will be briefly contacted by phone by the Research Assistant to thank them for their participation and to answer any study related questions.
End of study 6 month visit. Participants will engage in a virtual visit for end of study procedures. At this follow-up visit, the Research Assistant will assess for any adverse events and direct the participant to collect a fasting blood sample for repeat LDL-C measurement. The Research Assistant will administer an electronic survey and knowledge questionnaires. Additional clinical visits as desired by the participants' physicians will be allowed at their discretion.
- Conditions
- Lipid Metabolism Disorder
- Being tested
- Implementation Strategy Bundle, Usual care notification
- Keywords
- Blood Donors, High Cholesterol, LDL Cholesterol
- Medical subject headings
- Lipid Metabolism Disorders, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Strategy BundleBehavioural
Bundle includes multimodal communications to notify donors about high cholesterol and its treatment, website with resources, and an optional care navigator. Resources for their primary care provider will also be disseminated.
Usual care notificationOther
Carter BloodCare will notify participants of their high cholesterol, potential for genetic causes, and recommendation to see their care provider by sending its routine, standard notification letter. These participants will also be eligible to receive the intervention bundle at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Usual care) | Other | This arm will receive standard notification that is usually provided by Carter describing need to review with donor's primary care physician the presence of high cholesterol Receives: Other: Usual care notification |
| Intervention Group (Implementation strategy bundle) | Experimental | Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels) Receives: Behavioral: Implementation Strategy Bundle; Other: Usual care notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in LDL cholesterol levels from baseline to 6 months
This is the difference between the two study arms in change in LDL cholesterol level measurements obtained from lab work of blood samples from baseline and at 6 months
Measured: Baseline, 6 months
Secondary outcomes (4)
Difference in 6 month LDL-C values between the two treatment arms
This is the difference between the two study arms in the 6 month LDL cholesterol levels obtained from lab work of blood samples.
Measured: 6 months
Proportion of participants prescribed high-intensity statin therapy
Proportion of participants prescribed high-intensity statin therapy will be calculated as the number of patients who were prescribed high-intensity statin therapy in each arm divided by the total number of participants analyzed in each arm
Measured: 6 months
Proportion of participants prescribed any statin therapy
Proportion of participants prescribed any statin therapy will be calculated as the number of patients who were prescribed any statin therapy in each arm divided by the total number of participants analyzed in each arm
Measured: 6 months
Difference in participants' knowledge regarding FH at the end of study
Difference in participant's knowledge regarding FH at 6 months is measured using a validated FH knowledge survey where higher scores indicate greater knowledge. Comparisons between the two study arms will be made.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start27 Feb 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment assignment will be via block randomization stratified on age category in a 1:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Amit Khera, University of Texas Southwestern Medical Center
- Investigators
- Amit Khera, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693701
- Sponsor's protocol ID
- STU-2020-1366
- Other IDs
- 1R61HL161753-01
- Acronym
- DONATE-FH
- Status last verified
- Mar 2026
- First submitted
- 11 Jan 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05693701
- Acronym / sponsor ID
- DONATE-FH / STU-2020-1366
- Conditions
- Lipid Metabolism Disorder
- Keywords
- Blood Donors, High Cholesterol, LDL Cholesterol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 23 Jan 2023 (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.
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
Detailed description
This is a single center randomized, two arm trial. The two study arms include usual care (standard notification) and implementation bundle intervention. UT Southwestern Medical Center will be the main study site and Carter Blood Care will serve as the recruitment site.
Screening/Baseline visit: Donors agreeing to participate in the study will be informed of study procedures and will provide informed consent. A 20 mL blood sample as well as a urine sample will be obtained for eligibility screening laboratories and baseline LDL-C.
Follow-up phone call: At 3 months post-randomization, participants in both arms will be briefly contacted by phone by the Research Assistant to thank them for their participation and to answer any study related questions.
End of study 6 month visit. Participants will engage in a virtual visit for end of study procedures. At this follow-up visit, the Research Assistant will assess for any adverse events and direct the participant to collect a fasting blood sample for repeat LDL-C measurement. The Research Assistant will administer an electronic survey and knowledge questionnaires. Additional clinical visits as desired by the participants' physicians will be allowed at their discretion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment assignment will be via block randomization stratified on age category in a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Control group (Usual care) | Other | Other: Usual care notificationThis arm will receive standard notification that is usually provided by Carter describing need to review with donor's primary care physician the presence of high cholesterol |
| Intervention Group (Implementation strategy bundle) | Experimental | Behavioral: Implementation Strategy Bundle, Other: Usual care notificationAlong with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria
- Age 18 to 75 years
Key exclusion criteria (5 listed)
- Currently taking medication to lower cholesterol
- Taking any medication that can interact with statins
- Pregnancy
- Identified secondary cause of elevated lipids
- Chronic liver disease or significantly elevated liver function tests (> 3 times upper limit)
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 |
|---|---|---|
| Implementation Strategy BundleBundle includes multimodal communications to notify donors about high cholesterol and its treatment, website with resources, and an optional care navigator. Resources for their primary care provider will also be disseminated. | Behavioural | Intervention Group (Implementation strategy bundle) |
| Usual care notificationCarter BloodCare will notify participants of their high cholesterol, potential for genetic causes, and recommendation to see their care provider by sending its routine, standard notification letter. These participants will also be eligible to receive the intervention bundle at the end of the study. | Other | Control group (Usual care), Intervention Group (Implementation strategy bundle) |
Primary outcome
Difference in change in LDL cholesterol levels from baseline to 6 months
Time frame: Baseline, 6 months
This is the difference between the two study arms in change in LDL cholesterol level measurements obtained from lab work of blood samples from baseline and at 6 months
4 secondary outcomes
Difference in 6 month LDL-C values between the two treatment arms
Time frame: 6 months
Proportion of participants prescribed high-intensity statin therapy
Time frame: 6 months
Proportion of participants prescribed any statin therapy
Time frame: 6 months
Difference in participants' knowledge regarding FH at the end of study
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Amit Khera, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Strategy Bundle in people with Lipid Metabolism Disorder, run by University of Texas Southwestern Medical Center 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Khera, MD (214.645.7500, Amit.Khera@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in LDL cholesterol levels from baseline to 6 months (time frame: Baseline, 6 months). 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 17 Mar 2026.