Clinical trial NCT03430154: Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)
Official title: Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilia A, Haemophilia B, Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia and obesity/overweight, their caregivers/spouses/partners, and their healthcare providers (HCPs)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of obesity awareness and perceptions
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Prevalence of attitudes on obesity
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Prevalence of weight loss support structure
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Prevalence of interactions between patients and HCPs around obesity/overweight
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Prevalence of awareness about weight loss solutions
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Characteristics of obesity awareness and perceptions
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Characteristics of attitudes on obesity
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Characteristics of weight loss support structure
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Characteristics of interactions between patients and HCPs around obesity/overweight
timeFrame: Start of interviews day 1 until end of data collection day 90
measure: Characteristics of awareness about weight loss solutions
timeFrame: Start of interviews day 1 until end of data collection day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure' (1452)
role: STUDY_DIRECTOR
References: