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

September 4, 2018 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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
No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90
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
Start of interviews day 1 until end of data collection day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure' (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

April 29, 2018

Study Completion (Actual)

April 29, 2018

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAEM-4414
  • U1111-1199-8271 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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