Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE) (ACTION to HOPE)

Novo Nordisk

Status: Completed

Conditions: Haemophilia A, Haemophilia B, Obesity

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT03430154

HAEM-4414

U1111-1199-8271 (Other Identifier)

Details and patient eligibility

About

An online web-based cross-sectional survey in which participants will complete a distinct questionnaire for patients with hemophilia and obesity (PwHO) and/or their carers/spouses/partners, or a distinct questionnaire for healthcare professionals. Each questionnaire consists of more than 100 items including pre-coded (multiple choice) closed-ended questions, yes/no questions and rating scales. It is estimated that this one-off survey will take approximately 45-60 minutes to complete.

As a cross-sectional study, there will be no treatment of patients.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting one of the following criteria: a) Adults (any gender) aged equal to or more than 18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight, - OR - Caregivers of children (any gender) currently aged less than18 years with hemophilia (any severity, with or without inhibitors) caregiver-identified with obesity or overweight, - OR - Spouses or partners of adults (any gender) aged equal to or more than 18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight - OR - Healthcare professional (pediatric or adult hematologist, nurse, nurse practitioner, physician assistant, physical therapist, social worker) actively working in a federally designated hemophilia-treatment center for at least 3 years and with experience managing patients with hemophilia and obesity or overweight.
• Participants must have access to the internet, either at home or at a location convenient to them
• Provision of informed consent before the start of any survey-related activities.

Exclusion criteria

• Inability to understand and comply with written instructions in English
• Previous completion of this study with receipt of compensation
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Trial design

317 participants in 4 patient groups

Adults with hemophilia and obesity/overweight

Description:

Adults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight

Treatment:

Other: No treatment given

Caregivers identified with obesity/overweight

Description:

Caregivers of children (any gender) currently aged \<18 years with hemophilia (any severity, with or without inhibitors) caregiver-identified with obesity or overweight

Treatment:

Other: No treatment given

Spouses or partners self-identified with obesity/overweight

Description:

Spouses or partners of adults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight

Treatment:

Other: No treatment given

Healthcare profs. managing hemophilia and obesity/overweight

Description:

Healthcare professional (pediatric or adult hematologist, nurse, nurse practitioner, physician assistant, physical therapist, social worker) actively working in a federally designated hemophilia-treatment center for at least 3 years and with experience managing patients with hemophilia and obesity or overweight.

Treatment:

Other: No treatment given