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

Completed

• Conditions: Haemophilia A, Haemophilia B, Obesity
• Interventions: Other: No treatment given

• Registration Number: NCT03430154
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Primary Completion: 2018-04-29
• Study Completion: 2018-04-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with hemophilia and obesity/overweight	No treatment given	Adults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight
Caregivers identified with obesity/overweight	No treatment given	Caregivers of children (any gender) currently aged \<18 years with hemophilia (any severity, with or without inhibitors) caregiver-identified with obesity or overweight
Spouses or partners self-identified with obesity/overweight	No treatment given	Spouses or partners of adults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight
Healthcare profs. managing hemophilia and obesity/overweight	No treatment given	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of obesity awareness and perceptions	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Prevalence of attitudes on obesity	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Prevalence of weight loss support structure	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Prevalence of interactions between patients and HCPs around obesity/overweight	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Prevalence of awareness about weight loss solutions	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Characteristics of obesity awareness and perceptions	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Characteristics of attitudes on obesity	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Characteristics of weight loss support structure	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Characteristics of interactions between patients and HCPs around obesity/overweight	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires
Characteristics of awareness about weight loss solutions	Start of interviews day 1 until end of data collection day 90	Data is collected via online questionnaires

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Plainsboro, New Jersey, United States