Injury of Unknown Intent Due to Fall From HeightAAIU-PHOANCT01582464
Addressing Attitudes to Improve Use of Protective Headwear in Older Adults
An observational study of Injury of Unknown Intent Due to Fall From Height and Traumatic Brain Injury, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The goal of this phase of the project is to identify the elements of the Theory of Planned Behavior (TPB) that should be targeted to provide the most influence on older adults' behavior (or other stakeholders) to purchase and wear protective headwear. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injury of Unknown Intent Due to Fall From Height, Traumatic Brain Injury
- What is being tested?
- Social Marketing for protective headgear
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Mar 2013
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The population is English speaking male or female > 65 years of age who are competent to give informed consent.
Who may be able to join
- English speaking
- >= 65 years old
- Male or Female
- Competent to give informed consent
Who cannot join
- Non-English Speaking
- Not competent to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Social Marketing on Attitudes Towards Protective Headwear in Older Adults to Reduce Traumatic Brain Injury
The goal of this phase of the project is to identify the elements of the Theory of Planned Behavior (TPB) that should be targeted to provide the most influence on older adults' behavior (or other stakeholders) to purchase and wear protective headwear. The investigators also intend to determine the format of communication (social marketing/academic detailing) that is most influential for different key stakeholder groups. The TPB has been useful in understanding behavior change related to exercise and adaptive equipment use (such as grab bars, canes, hip protectors); in understanding how a person's attitudes, subjective/social norms and perceived behavioral control inform the development of intention that leads to behavior change.
Read the detailed description
- Design of Social Marketing/Consumer Preferences Trial
- Development of Protective Headwear Attitudes Questionnaire To develop a questionnaire specific to attitudes about protective headwear, the authors reviewed existing papers that applied the Theory of Planned Behavior to other health behaviors such as the use of canes or walkers and adherence to exercise. Questions were drafted to address attitudes (24), subjective norms (14) and perceived behavioral control (14) about the behavior of using protective headwear. The rationale and specific questions were presented to an expert panel and clinicians (behavioralist, 3 geriatricians, long-term care nurse and a nurse health services researcher) to evaluate the content and face validity of each question, and to rank each as high or low importance within each domain. Item reduction and refinement following the expert panels identified 26 candidate questions. Analysis of the PHAQ as an instrumented was also completed
- Social Marketing Approach
- Expert panel Input on social marketing materials Input on the social marketing phase was conducted on two focus groups of 6 clinicians, geriatricians and nurses, and the social marketing tools were updated and improved in a CQI manner after each focus group with experts and with seniors in retirement communities. Please review transcripts on the input from seniors.
- Social Marketing Focus groups/Process The social marketing approach was developed and refined using a structured interview approach with each focus group of older adults. A total 6 focus groups were conducted at 4 communities with a total of 36 participants. An iterative process was used to improve the content of the social marketing after each session. The goal was to develop a progressive method of presenting information about the magnitude of head injuries and the development of a new product that we wanted their input towards the final design. The progression was done with First, a one page flier, Second, a three minute video tape and Finally, a two page article that was patterned after articles that appear in AARP magazine. The flier provided basic information about the risk of TBI and the development of a new product called SMARTY®, which is made of advanced materials so that it is lightweight and can be styled to match the needs of the user and setting. The Video included the discussion of the unrecognized public health issue by one of the authors (SC), photos of the advanced materials and how they work to provide protection, a videotape of the testing of the protective headwear by dropping a crash test dummy and finally the testimonial of the user of a prototype by a colleague who has a seizure disorder. The paper provides more detail and includes a graph of the rapid increase in deaths from TBI in older adults 75 years and over, and a drawing that describes the characteristics of the advanced materials.
- Ability to change attitudes To measure changes in attitudes, the participants were given the PHAQ, as well as the demographic and functional status questionnaire when they arrived for the focus group. Input into the social marketing content was sought in a structured interview manner, and by using an audience response system with questions projected by power point. At the conclusion of the social marketing, the PHAQ was repeated and sent to participants 2 weeks after the focus group to gage stability of changes in attitudes.
- Being tested
- Social Marketing for protective headgear
- Keywords
- Protective Headwear, Social Marketing, Theory of Planned Behavior
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Marketing for protective headgearBehavioural
Also called SMARTY and commercially available protective Headgear
Social marketing was done using a CQI manner after each focus group with experts and with seniors using a structured interview approach with an iterative process to develop a progressive method of presenting information about head injuries and their input on a new prevention.
To measure changes in attitudes, the participants were given an attitudes questionnaire (PHAQ), \& a demographic \& functional status questionnaire. Input into the social marketing content was sought in a structured interview manner, and by using an audience response system with questions projected by power point. At the conclusion of the social marketing, the PHAQ was repeated and sent to participants 2 weeks after the focus group to gage stability of changes in attitudes.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults in a Senior Community | Residents of a Continuing Care Retirement Community (CCRC) that is a part of The Be Group (previously known as Southern California Presbyterian Homes), with no exclusion other than being able to communicate in English and provide consent to participate. Receives: Behavioral: Social Marketing for protective headgear |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Unknown Intent Due to Fall From HeightStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven C. Castle, MD, University of California, Los Angeles
- Investigators
- Steven Castle, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582464
- Sponsor's protocol ID
- 2010-012
- Acronym
- AAIU-PHOA
- Status last verified
- May 2016
- First submitted
- 18 Apr 2012
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: all data shared will be de-identified
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Social Marketing on Attitudes Towards Protective Headwear in Older Adults to Reduce Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01582464
- Acronym / sponsor ID
- AAIU-PHOA / 2010-012
- Keywords
- Protective Headwear, Social Marketing, Theory of Planned Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Apr 2012 (estimated)
- 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.
The goal of this phase of the project is to identify the elements of the Theory of Planned Behavior (TPB) that should be targeted to provide the most influence on older adults' behavior (or other stakeholders) to purchase and wear protective headwear. The investigators also intend to determine the format of communication (social marketing/academic detailing) that is most influential for different key stakeholder groups. The TPB has been useful in understanding behavior change related to exercise and adaptive equipment use (such as grab bars, canes, hip protectors); in understanding how a person's attitudes, subjective/social norms and perceived behavioral control inform the development of intention that leads to behavior change.
Detailed description
- Design of Social Marketing/Consumer Preferences Trial
- Development of Protective Headwear Attitudes Questionnaire To develop a questionnaire specific to attitudes about protective headwear, the authors reviewed existing papers that applied the Theory of Planned Behavior to other health behaviors such as the use of canes or walkers and adherence to exercise. Questions were drafted to address attitudes (24), subjective norms (14) and perceived behavioral control (14) about the behavior of using protective headwear. The rationale and specific questions were presented to an expert panel and clinicians (behavioralist, 3 geriatricians, long-term care nurse and a nurse health services researcher) to evaluate the content and face validity of each question, and to rank each as high or low importance within each domain. Item reduction and refinement following the expert panels identified 26 candidate questions. Analysis of the PHAQ as an instrumented was also completed
- Social Marketing Approach
- Expert panel Input on social marketing materials Input on the social marketing phase was conducted on two focus groups of 6 clinicians, geriatricians and nurses, and the social marketing tools were updated and improved in a CQI manner after each focus group with experts and with seniors in retirement communities. Please review transcripts on the input from seniors.
- Social Marketing Focus groups/Process The social marketing approach was developed and refined using a structured interview approach with each focus group of older adults. A total 6 focus groups were conducted at 4 communities with a total of 36 participants. An iterative process was used to improve the content of the social marketing after each session. The goal was to develop a progressive method of presenting information about the magnitude of head injuries and the development of a new product that we wanted their input towards the final design. The progression was done with First, a one page flier, Second, a three minute video tape and Finally, a two page article that was patterned after articles that appear in AARP magazine. The flier provided basic information about the risk of TBI and the development of a new product called SMARTY®, which is made of advanced materials so that it is lightweight and can be styled to match the needs of the user and setting. The Video included the discussion of the unrecognized public health issue by one of the authors (SC), photos of the advanced materials and how they work to provide protection, a videotape of the testing of the protective headwear by dropping a crash test dummy and finally the testimonial of the user of a prototype by a colleague who has a seizure disorder. The paper provides more detail and includes a graph of the rapid increase in deaths from TBI in older adults 75 years and over, and a drawing that describes the characteristics of the advanced materials.
- Ability to change attitudes To measure changes in attitudes, the participants were given the PHAQ, as well as the demographic and functional status questionnaire when they arrived for the focus group. Input into the social marketing content was sought in a structured interview manner, and by using an audience response system with questions projected by power point. At the conclusion of the social marketing, the PHAQ was repeated and sent to participants 2 weeks after the focus group to gage stability of changes in attitudes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults in a Senior Community | – | Behavioral: Social Marketing for protective headgearResidents of a Continuing Care Retirement Community (CCRC) that is a part of The Be Group (previously known as Southern California Presbyterian Homes), with no exclusion other than being able to communicate in English and provide consent to participate. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The population is English speaking male or female > 65 years of age who are competent to give informed consent.
Key inclusion criteria (4 listed)
- English speaking
- >= 65 years old
- Male or Female
- Competent to give informed consent
Key exclusion criteria (2 listed)
- Non-English Speaking
- Not competent to give informed consent
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 |
|---|---|---|
| Social Marketing for protective headgearAlso: SMARTY and commercially available protective HeadgearSocial marketing was done using a CQI manner after each focus group with experts and with seniors using a structured interview approach with an iterative process to develop a progressive method of presenting information about head injuries and their input on a new prevention. To measure changes in attitudes, the participants were given an attitudes questionnaire (PHAQ), \& a demographic \& functional status questionnaire. Input into the social marketing content was sought in a structured interview manner, and by using an audience response system with questions projected by power point. At the conclusion of the social marketing, the PHAQ was repeated and sent to participants 2 weeks after the focus group to gage stability of changes in attitudes. | Behavioural | Older Adults in a Senior Community |
Primary outcome
Not reported in the source record.
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 9 May 2016.
- Individual participant dataSharing planned: No. all data shared will be de-identified
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.
Steven Castle, MD principal investigator
University of California, Los Angeles
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 Injury of Unknown Intent Due to Fall From Height and Traumatic Brain Injury, run by University of California, Los Angeles 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 4 inclusion and 2 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 9 May 2016. 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.
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 9 May 2016.