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

NCT03430154 | Completed FDA Drug

• 2 other identifiers: HAEM-4414U1111-1199-8271
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemophilia A, Haemophilia B, Obesity

Outcome Measures

Primary Outcomes (10)

• Prevalence of obesity awareness and perceptions

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Prevalence of attitudes on obesity

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Prevalence of weight loss support structure

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Prevalence of interactions between patients and HCPs around obesity/overweight

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Prevalence of awareness about weight loss solutions

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Characteristics of obesity awareness and perceptions

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Characteristics of attitudes on obesity

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Characteristics of weight loss support structure

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Characteristics of interactions between patients and HCPs around obesity/overweight

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

• Characteristics of awareness about weight loss solutions

  Data is collected via online questionnaires

  Start of interviews day 1 until end of data collection day 90

Study Arms (4)

Adults with hemophilia and obesity/overweight

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

Other: No treatment given

Caregivers identified with obesity/overweight

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

Other: No treatment given

Spouses or partners self-identified with obesity/overweight

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

Other: No treatment given

Healthcare profs. managing hemophilia and obesity/overweight

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.

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

Adults with hemophilia and obesity/overweight; Caregivers identified with obesity/overweight; Healthcare profs. managing hemophilia and obesity/overweight; Spouses or partners self-identified with obesity/overweight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilia and obesity/overweight, their caregivers/spouses/partners, and their healthcare providers (HCPs)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B; Obesity

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Reporting Anchor and Disclosure' (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 12, 2018
• Study Start: December 1, 2017
• Primary Completion: April 29, 2018
• Study Completion: April 29, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)