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OpenTrials
Completed

NCT Number: NCT03430154

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

  1. Prevalence of obesity awareness and perceptions

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  2. Prevalence of attitudes on obesity

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  3. Prevalence of weight loss support structure

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  4. Prevalence of interactions between patients and HCPs around obesity/overweight

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  5. Prevalence of awareness about weight loss solutions

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  6. Characteristics of obesity awareness and perceptions

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  7. Characteristics of attitudes on obesity

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  8. Characteristics of weight loss support structure

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  9. Characteristics of interactions between patients and HCPs around obesity/overweight

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

  10. Characteristics of awareness about weight loss solutions

    Time frame: Start of interviews day 1 until end of data collection day 90

    Data is collected via online questionnaires

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: ACTION to HOPE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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