Haemophilia A, Haemophilia B, Obesity Clinical Trial
— ACTION to HOPEOfficial title:
Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)
| Verified date | September 2018 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 317 |
| Est. completion date | April 29, 2018 |
| Est. primary completion date | April 29, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Novo Nordisk Investigational Site | Plainsboro | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of obesity awareness and perceptions | Data is collected via online questionnaires | Start of interviews day 1 until end of data collection day 90 | |
| Primary | Prevalence of attitudes on obesity | Data is collected via online questionnaires | Start of interviews day 1 until end of data collection day 90 | |
| Primary | Prevalence of weight loss support structure | Data is collected via online questionnaires | Start of interviews day 1 until end of data collection day 90 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Characteristics of obesity awareness and perceptions | Data is collected via online questionnaires | Start of interviews day 1 until end of data collection day 90 | |
| Primary | Characteristics of attitudes on obesity | Data is collected via online questionnaires | Start of interviews day 1 until end of data collection day 90 | |
| Primary | Characteristics of weight loss support structure | Data is collected via online questionnaires | Start of interviews day 1 until end of data collection day 90 | |
| Primary | 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 | |
| Primary | 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 |