DeathNCT01008241
South Florida Residents Knowledge and Opinions on End-of-Life Issues
An observational study of Death, run by Maria Isabel Fernandez at 2 sites in United States.
Trial summary
The goal of this cross-sectional study is to gain an understanding of the knowledge and attitudes regarding end of life issues and hospice care among a sample of residents of South Florida. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Death
- What is being tested?
- Paper questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 361 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Mar 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult residents of South Florida
Who may be able to join
- 18 years of age or greater
- Resident of Broward or Miami-Dade counties
Who cannot join
- Less than 18 years of age
- Not currently residing in Broward or Miami-Dade counties
Trial locations and contacts
2 sites in 1 country.
United States2 sites
A variety of public venues in Broward County
Fort Lauderdale, Florida, 33314
A variety of public venues in Miami-Dade County
Miami, Florida, 33140
About this study
Official title: Project Hope: Survey of South Florida Residents Knowledge and Opinions on End-of-Life Issues
The goal of this cross-sectional study is to gain an understanding of the knowledge and attitudes regarding end of life issues and hospice care among a sample of residents of South Florida. This study is being conducted by 3rd year Osteopathic Medical Student (OMS-III)Nova Southeastern University College of Osteopathic Medicine (NSU COM) research fellow Heather Ruff as part of the research fellowship requirements.
Participants will complete a paper and pencil questionnaire that measures 4 domains of interest (advanced care planning; end of life care; hospice care and death and dying) as well as demographic factors (age, marital status, education etc.). It is estimated that the survey will take 15 minutes to complete. Data will be collected anonymously, with no personal identifying information. The instructions on the questionnaire state that by completing the questionnaire, the participant is providing consent to participate in the study. We will use time and space sampling methods to recruit up to 250 participants at community venues (i.e., beaches, street corners, parks, pedestrian malls, and other public venues were people congregate) in South Florida. At each venue, we will define a specific area; persons who enter the defined area will be approached, screened for eligibility (18 years of age or older and a resident of South Florida), and if eligible, invited to participate by trained research staff. Sampling intervals will be determined by traffic flow at each venue. If a person agrees to participate they will be given a paper and pencil copy of the survey to complete on the spot. Participants will be given a token of appreciation. Data entry and data analyses will be done using Statistical Package for the Social Sciences (SPSS).
Read the detailed description
The survey instrument included questions about demographics (constructed by the researchers), including the participants' age, gender, ethnicity, relationship status, education level, income, and whether they had a religious affiliation. Also included were items about steps participants may have taken to plan for their health care in the event they were unable to make personal health care decisions, such as whether they had a living well or durable power of attorney for health care, and whether they had knowledge of the existence of these documents prior to taking the survey. Participants were also asked where/from whom they first learned about hospice and where they got most of their knowledge about hospice. Hospice. This scale contained 24 statements about knowledge and opinions on hospice care. Hospice was defined as a program that provides care to people with illnesses that cannot be cured when they are at the end of their lives. Participants were asked to report their feelings from 1 (strongly disagree) to 5 (strongly agree) about each statement. Items included (a) ''Hospice care means giving up,'' (b) ''Hospice care means you get no treatment,'' (c) ''Hospice care can be provided in a patient's home if the patient or family wishes it,'' and (d) ''Those who believe in God do not need hospice.'' More favorable attitudes toward hospice are evidenced in higher scores. End of life care. Seven Likert-type items were used to ask participants about their thoughts and feelings related to the kind of medical care they would want if they had a disease, like cancer, that could not be cured. When answering these questions, participants were asked to consider a hypothetical situation in which they had a terminal disease and not consider their current state of health. This scale is composed of 7 items and uses a 5-point Likert-type response ranging from 1 (strongly disagree) to 5 (strongly agree). Participants were asked items such as
(a) ''If I had a disease (like cancer) that the doctors could not cure, I would want to live as long as possible even if I had to be on life support or a breathingmachine,'' and (b) ''If I had a disease (like cancer) that could not be cured, decreasing pain would be more important to me than living as long as possible.'' Higher scores indicate higher levels of advanced planning for EOL care. Communication about death and dying. Death and dying communication was measured using 9 items rated on a 5-point Likert format, with responses ranging from 1 (strongly disagree) to 5 (strongly agree). Examples of items include
- ''I feel comfortable talking about death in general,''
- ''Dying is a normal part of life,'' and (c) ''Death should be avoided at all costs.'' Higher scores indicate greater comfort with communicating about death and dying. Through convenience sampling strategies, a total of 625 individuals were approached; 610 were eligible, and 361 participants returned the survey. Thirty questionnaires were dropped because less than two thirds of the scale items were completed), resulting in a sample size of 331. Due to low numbers in some demographic categories, educational level was collapsed into 3 categories (ie, high school/some college, associate/ bachelors degree, and graduate degree) and annual income was collapsed into ''less than US$25 000, $25 000 to US$49 999, and US$50 000 or more. Ethnicity was categorized as non-Hispanic white, black, Hispanic, and other/mixed race. Relationship status was dichotomized into ''have a partner'' and ''do not have a partner.''
- Conditions
- Death
- Being tested
- Paper questionnaire
- Keywords
- Hospice, End of Life, Knowledge, Attitudes, Opinions, Advanced Care Planning, Death and Dying, Communication
- Medical subject headings
- Death, Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper questionnaireBehavioural
Participants will complete a paper and pencil questionnaire that measures 4 domains of interest (advanced care planning; end of life care; hospice care and death and dying) as well as demographic factors (age, marital status, education etc.)
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Convenience sample of adult residents of South Florida Receives: Behavioral: Paper questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
attitudes towards end of life issues
brief attitude scale to document perceptions of end of life issues
Measured: one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeathStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Isabel Fernandez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Isabel Fernandez, Nova Southeastern University
- Investigators
- Heather M Ruff, B.S., Principal investigator, Nova Southeastern University College of Osteopathic MedicineMaria I Fernandez, Ph.D., Study chair, Nova Southeastern University College of Osteopathic MedicineStephen Bowen, M.D., M.P.H., Study chair, Nova Southeastern University College of Osteopathic MedicineRobin J Jacobs, Ph.D., Study chair, Nova Southeastern University College of Osteopathic MedicineHilary Gerber, B.S., Study chair, Nova Southeastern University College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008241
- Sponsor's protocol ID
- Project Hope
- Status last verified
- Apr 2023
- First submitted
- 3 Nov 2009
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Hope: Survey of South Florida Residents Knowledge and Opinions on End-of-Life Issues
- ClinicalTrials.gov ID
- NCT01008241
- Acronym / sponsor ID
- Project Hope
- Conditions
- Death
- Keywords
- Hospice, End of Life, Knowledge, Attitudes, Opinions, Advanced Care Planning, Death and Dying, Communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Maria Isabel FernandezUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Nov 2009 (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 cross-sectional study is to gain an understanding of the knowledge and attitudes regarding end of life issues and hospice care among a sample of residents of South Florida. This study is being conducted by 3rd year Osteopathic Medical Student (OMS-III)Nova Southeastern University College of Osteopathic Medicine (NSU COM) research fellow Heather Ruff as part of the research fellowship requirements.
Participants will complete a paper and pencil questionnaire that measures 4 domains of interest (advanced care planning; end of life care; hospice care and death and dying) as well as demographic factors (age, marital status, education etc.). It is estimated that the survey will take 15 minutes to complete. Data will be collected anonymously, with no personal identifying information. The instructions on the questionnaire state that by completing the questionnaire, the participant is providing consent to participate in the study. We will use time and space sampling methods to recruit up to 250 participants at community venues (i.e., beaches, street corners, parks, pedestrian malls, and other public venues were people congregate) in South Florida. At each venue, we will define a specific area; persons who enter the defined area will be approached, screened for eligibility (18 years of age or older and a resident of South Florida), and if eligible, invited to participate by trained research staff. Sampling intervals will be determined by traffic flow at each venue. If a person agrees to participate they will be given a paper and pencil copy of the survey to complete on the spot. Participants will be given a token of appreciation. Data entry and data analyses will be done using Statistical Package for the Social Sciences (SPSS).
Detailed description
The survey instrument included questions about demographics (constructed by the researchers), including the participants' age, gender, ethnicity, relationship status, education level, income, and whether they had a religious affiliation. Also included were items about steps participants may have taken to plan for their health care in the event they were unable to make personal health care decisions, such as whether they had a living well or durable power of attorney for health care, and whether they had knowledge of the existence of these documents prior to taking the survey. Participants were also asked where/from whom they first learned about hospice and where they got most of their knowledge about hospice. Hospice. This scale contained 24 statements about knowledge and opinions on hospice care. Hospice was defined as a program that provides care to people with illnesses that cannot be cured when they are at the end of their lives. Participants were asked to report their feelings from 1 (strongly disagree) to 5 (strongly agree) about each statement. Items included (a) ''Hospice care means giving up,'' (b) ''Hospice care means you get no treatment,'' (c) ''Hospice care can be provided in a patient's home if the patient or family wishes it,'' and (d) ''Those who believe in God do not need hospice.'' More favorable attitudes toward hospice are evidenced in higher scores. End of life care. Seven Likert-type items were used to ask participants about their thoughts and feelings related to the kind of medical care they would want if they had a disease, like cancer, that could not be cured. When answering these questions, participants were asked to consider a hypothetical situation in which they had a terminal disease and not consider their current state of health. This scale is composed of 7 items and uses a 5-point Likert-type response ranging from 1 (strongly disagree) to 5 (strongly agree). Participants were asked items such as
(a) ''If I had a disease (like cancer) that the doctors could not cure, I would want to live as long as possible even if I had to be on life support or a breathingmachine,'' and (b) ''If I had a disease (like cancer) that could not be cured, decreasing pain would be more important to me than living as long as possible.'' Higher scores indicate higher levels of advanced planning for EOL care. Communication about death and dying. Death and dying communication was measured using 9 items rated on a 5-point Likert format, with responses ranging from 1 (strongly disagree) to 5 (strongly agree). Examples of items include
- ''I feel comfortable talking about death in general,''
- ''Dying is a normal part of life,'' and (c) ''Death should be avoided at all costs.'' Higher scores indicate greater comfort with communicating about death and dying. Through convenience sampling strategies, a total of 625 individuals were approached; 610 were eligible, and 361 participants returned the survey. Thirty questionnaires were dropped because less than two thirds of the scale items were completed), resulting in a sample size of 331. Due to low numbers in some demographic categories, educational level was collapsed into 3 categories (ie, high school/some college, associate/ bachelors degree, and graduate degree) and annual income was collapsed into ''less than US$25 000, $25 000 to US$49 999, and US$50 000 or more. Ethnicity was categorized as non-Hispanic white, black, Hispanic, and other/mixed race. Relationship status was dichotomized into ''have a partner'' and ''do not have a partner.''
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Behavioral: Paper questionnaireConvenience sample of adult residents of South Florida |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult residents of South Florida
Key inclusion criteria (2 listed)
- 18 years of age or greater
- Resident of Broward or Miami-Dade counties
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Not currently residing in Broward or Miami-Dade counties
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 |
|---|---|---|
| Paper questionnaireParticipants will complete a paper and pencil questionnaire that measures 4 domains of interest (advanced care planning; end of life care; hospice care and death and dying) as well as demographic factors (age, marital status, education etc.) | Behavioural | Study Group |
Primary outcome
attitudes towards end of life issues
Time frame: one time point
brief attitude scale to document perceptions of end of life issues
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 25 Apr 2023.
Related trials for Death
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Heather M Ruff, B.S. principal investigator
Nova Southeastern University College of Osteopathic Medicine
Maria I Fernandez, Ph.D. study chair
Nova Southeastern University College of Osteopathic Medicine
Stephen Bowen, M.D., M.P.H. study chair
Nova Southeastern University College of Osteopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death, run by Maria Isabel Fernandez at 2 sites 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 2 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
attitudes towards end of life issues (time frame: one time point). 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 25 Apr 2023.