Addressing Attitudes to Improve Use of Protective Headwear in Older Adults (AAIU-PHOA)

May 6, 2016 updated by: Steven C. Castle, MD, University of California, Los Angeles

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Design of Social Marketing/Consumer Preferences Trial

    a. 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

  2. Social Marketing Approach

    1. 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.

    2. 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.

    3. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

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
    • California
      • Multiple, California, United States, 91203
        • Be.Group Facilities

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population is English speaking male or female > 65 years of age who are competent to give informed consent.

Description

Inclusion Criteria:

  • English speaking
  • >= 65 years old
  • Male or Female
  • Competent to give informed consent

Exclusion Criteria:

  • Non-English Speaking
  • Not competent to give informed consent

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Social Marketing for 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.

Other Names:
  • SMARTY and commercially available protective Headgear

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Castle, MD, University of California, Los Angeles

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

all data shared will be de-identified

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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