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Protocol - Adherence to Prophylactic Clotting Factor Treatment Regimens in Hemophilia

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Description:

The Validated Hemophilia Regimen Treatment Adherence Scale - Prophylaxis (VERITAS-Pro™) is a 24-item, self-administered questionnaire that includes measures adherence to a prophylactic treatment regimen of infused Factor VIII or Factor IX concentrate.

Specific Instructions:

The Validated Hemophilia Regimen Treatment Adherence Scale - Prophylaxis (VERITAS-Pro™) is a copyrighted instrument. Investigators should contact Natalie A. Duncan at the Indiana Hemophilia and Thrombosis Center to obtain a copy of the scale (see "Source").

Protocol:

Summary of the Validated Hemophilia Regimen Treatment Adherence Scale - Prophylaxis (VERITAS-Pro™)

The Validated Hemophilia Regimen Treatment Adherence Scale - Prophylaxis (VERITAS-Pro™) is a 24-item self-administered questionnaire that includes six subscales: Time, Dose, Plan, Remember, Skip, and Communicate. Each subscale includes four items which are rated on a 5-point Likert scales ranging from "Always" to "Never." Items can be scored in different directions depending on whether their wording reflects adherence or non-adherence. Each rating on the 5-point scale has a numeric score; the response indicating the "best" adherence is 1 point and the response indicating the "worst" adherence is 5 points. Subscale scores range from four points (most adherent) to 20 points (least adherent). Total scores range from 24 (most adherent) to 120 (least adherent).

The Validated Hemophilia Regimen Treatment Adherence Scale - Prophylaxis (VERITAS-Pro™) is a copyrighted instrument. Investigators should contact Natalie A. Duncan at the Indiana Hemophilia and Thrombosis Center to obtain a copy of the scale (see "Source").None

Protocol Name from Source:

Validated Hemophilia Regimen Treatment Adherence Scale - Prophylaxis (VERITAS-Pro™)

Availability:

Publicly available

Personnel and Training Required

None

Equipment Needs
None
Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Self- or proxy-administered questionnaire

Life Stage:

Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants:

Patient or parent/caregiver with the primary responsibility for administering prophylactic Factor VIII or Factor IX infusions.

Selection Rationale

The VERITAS-Pro™ is a valid, reliable, self-administered questionnaire that is easy to use, score, and interpret.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Population Pharmacokinetic Study Coagulation Factor VIII Standard Half Life Chromogenic Substrate Clotting Factor Assay 6712217 CDE Browser
Derived Variables

None

Process and Review

Not applicable.

Source

The Validated Hemophilia Regimen Treatment Adherence Scale - Prophylaxis (VERITAS-Pro™) may be obtained by contacting:

Natalie A. Duncan, MPH

Indiana Hemophilia and Thrombosis Center

8402 Harcourt Road

Suite 500

Indianapolis, IN 46260, USA

Telephone: +1 317 871 0011 (ext. 273)

Fax: +1 317 829 7786

E-mail: nduncan@ihtc.org

Duncan, N. A., Kronenberger W. G., Roberson C. P., & Shapiro A. D. (2010). VERITAS-Pro™: A new measure of adherence to prophylactic regimens in haemophilia. Haemophilia, 16, 247-255.

General References

Thornburg, C. D., & Duncan, N. A. (2017). Treatment adherence in hemophilia. Patient Preference and Adherence, 11, 1677-1686.

van Os, S. B., Troop, N. A., Sullivan, K. R., & Hart, D. P. (2017). Adherence to prophylaxis in adolescents and young adults with severe haemophilia: A quantitative study with patients. PLoS One, 12(1), e0169880.

Protocol ID:

911601

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX911601000000 Protocol 911601 - proprietary. Check DCW for more
contact. show less
N/A
Hemophilia Inhibitor Research
Measure Name:

Patient Recall of Clotting Factor Administration

Release Date:

May 7, 2019

Definition

Patient-reported adherence to a recommended self-administered prophylactic treatment regimen of clotting factor concentrate.

Purpose

In hemophilia, adherence to recommended prophylactic treatment regimens has been shown to increase treatment effectiveness and is associated with better clinical outcomes (e.g., annual bleeding rate) and quality of life.

Keywords

Hemophilia, prophylactic treatment, hemophilia A, hemophilia B, Factor VIII, FVIII, Factor IX, FIX, episodic treatment, adherence