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Multicomponent Intervention Study- Blood Donors With High Cholesterol (DONATE-FH)

Primary Purpose

Lipid Metabolism Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implementation Strategy Bundle
Usual care notification
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lipid Metabolism Disorder focused on measuring Blood Donors, High Cholesterol, LDL Cholesterol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria Age 18 to 75 years Exclusion Criteria: 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)

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group (Usual care)

Intervention Group (Implementation strategy bundle)

Arm Description

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

Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
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.

Full Information

First Posted
January 11, 2023
Last Updated
February 27, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05693701
Brief Title
Multicomponent Intervention Study- Blood Donors With High Cholesterol
Acronym
DONATE-FH
Official Title
Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
February 28, 2027 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorder
Keywords
Blood Donors, High Cholesterol, LDL Cholesterol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment assignment will be via block randomization stratified on age category in a 1:1 allocation ratio.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (Usual care)
Arm Type
Other
Arm Description
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
Arm Title
Intervention Group (Implementation strategy bundle)
Arm Type
Experimental
Arm Description
Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)
Intervention Type
Behavioral
Intervention Name(s)
Implementation Strategy Bundle
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care notification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in change in LDL cholesterol levels from baseline to 6 months
Description
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
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Difference in 6 month LDL-C values between the two treatment arms
Description
This is the difference between the two study arms in the 6 month LDL cholesterol levels obtained from lab work of blood samples.
Time Frame
6 months
Title
Proportion of participants prescribed high-intensity statin therapy
Description
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
Time Frame
6 months
Title
Proportion of participants prescribed any statin therapy
Description
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
Time Frame
6 months
Title
Difference in participants' knowledge regarding FH at the end of study
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria Age 18 to 75 years Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Khera, MD
Phone
214.645.7500
Email
Amit.Khera@UTSouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sneha Deodhar, MS
Phone
214.648.2872
Email
Sneha.Deodhar@UTSouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Khera, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sneha Deodhar, MS
Phone
214-648-2878
Email
BloodDonorStudy@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Amit Khera, MD
Email
BloodDonorStudy@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Amit Khera, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multicomponent Intervention Study- Blood Donors With High Cholesterol

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