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Protocol - Adherence to Episodic Clotting Factor Treatment Regimens in Hemophilia

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Description:

The Validated Hemophilia Regimen Treatment Adherence Scale - On-Demand (VERITAS-PRN™) is a 24-item, self-administered questionnaire that includes measures adherence to an episodic treatment regimen of infused Factor VIII or Factor IX concentrate in response to acute bleeding episodes.

Specific Instructions:

The Validated Hemophilia Regimen Treatment Adherence Scale - On-Demand (VERITAS-PRN™) 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:

Validated Hemophilia Regimen Treatment Adherence Scale - On-Demand (VERITAS-PRN™)

The Validated Hemophilia Regimen Treatment Adherence Scale - On-Demand (VERITAS-PRN™) is a 24-item, self-administered questionnaire divided into six 4-item subscales: Treat (infusing as recommended), Time (infusing promptly after onset of symptoms), Dose (infusing the proper dose), Plan (planning in order to have supplies on hand), Remember (remembering when and how to infuse) and Communicate (contacting the HTC as appropriate for assistance). 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 4 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 - On-Demand (VERITAS-PRN™) 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 Name from Source:

Validated Hemophilia Regimen Treatment Adherence Scale - On-Demand (VERITAS-PRN™)

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 episodic Factor VIII or Factor IX infusions.

Selection Rationale

The Validated Hemophilia Regimen Treatment Adherence Scale - On-Demand (VERITAS-PRN™) is a valid, reliable, self-administered questionnaire that is easy to use, score, and interpret.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Population Pharmacokinetic Study Coagulation Factor VIII Extend Half Life Chromogenic Substrate Clotting Factor Assay 6712218 CDE Browser
Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

The Validated Hemophilia Regimen Treatment Adherence Scale - On-Demand (VERITAS-PRN™) 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

McLaughlin, J. M., Witkop, M. L., Lambing, A., Anderson, T. L., Munn, J., & Tortella, B. (2014). Better adherence to prescribed treatment regimen is related to less chronic pain among adolescents and young adults with moderate or severe haemophilia. Haemophilia, 20(4), 506-512.

Tran, D. Q., Barry, V., Antun, A., Ribeiro, M., Stein, S., & Kempton, C. L. (2017). Physician trust and depression influence adherence to factor replacement: A single-centre cross-sectional study. Haemophilia, 23(1), 98-104.

Protocol ID:

911602

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
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