Haemophilia A, Haemophilia B, ObesityACTION to HOPENCT03430154
Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)
An observational study of Haemophilia A, Haemophilia B, Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemophilia A, Haemophilia B, Obesity
- What is being tested?
- No treatment given
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 29 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with hemophilia and obesity/overweight, their caregivers/spouses/partners, and their healthcare providers (HCPs)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Plainsboro, New Jersey, 08536
About this study
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
- Being tested
- No treatment given
- Medical subject headings
- Hemophilia A, Hemophilia B, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obesity awareness and perceptions
Data is collected via online questionnaires
Measured: Start of interviews day 1 until end of data collection day 90
Prevalence of attitudes on obesity
Data is collected via online questionnaires
Measured: Start of interviews day 1 until end of data collection day 90
Prevalence of weight loss support structure
Data is collected via online questionnaires
Measured: 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
Measured: 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
Measured: Start of interviews day 1 until end of data collection day 90
Characteristics of obesity awareness and perceptions
Data is collected via online questionnaires
Measured: Start of interviews day 1 until end of data collection day 90
Characteristics of attitudes on obesity
Data is collected via online questionnaires
Measured: Start of interviews day 1 until end of data collection day 90
Characteristics of weight loss support structure
Data is collected via online questionnaires
Measured: 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
Measured: 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
Measured: Start of interviews day 1 until end of data collection day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Dec 2017
- Primary completion29 Apr 2018
- Study completion29 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia A, Haemophilia B, ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure' (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430154
- Sponsor's protocol ID
- HAEM-4414
- Other IDs
- U1111-1199-8271
- Acronym
- ACTION to HOPE
- Status last verified
- Sep 2018
- First submitted
- 16 Jan 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)
- ClinicalTrials.gov ID
- NCT03430154
- Acronym / sponsor ID
- ACTION to HOPE / HAEM-4414
- Conditions
- Haemophilia A, Haemophilia B, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 29 Apr 2018 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adults with hemophilia and obesity/overweight | – | Other: No treatment givenAdults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight |
| Caregivers identified with obesity/overweight | – | Other: No treatment givenCaregivers of children (any gender) currently aged <18 years with hemophilia (any severity, with or without inhibitors) caregiver-identified with obesity or overweight |
| Spouses or partners self-identified with obesity/overweight | – | Other: No treatment givenSpouses or partners of adults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight |
| Healthcare profs. managing hemophilia and obesity/overweight | – | Other: No treatment givenHealthcare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with hemophilia and obesity/overweight, their caregivers/spouses/partners, and their healthcare providers (HCPs)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment given | Other | 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 |
Primary outcome
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure' (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A, Haemophilia B, Obesity, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of obesity awareness and perceptions (time frame: Start of interviews day 1 until end of data collection day 90). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.