Cardiovascular DiseaseNCT00983333
Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program
A study testing Time to Talk CARDIO website in people with Cardiovascular Disease and Cardiovascular Risk Factors, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This research focuses on communication practices between patients and health care professionals, like nurses, doctors, or physician assistants. The goal is to help improve communication about heart health issues. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Cardiovascular Disease, Cardiovascular Risk Factors
- What is being tested?
- Time to Talk CARDIO website
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2009
- Phase
- Interventional
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55-70 years
- English is preferred language
- Has one or more chronic cardiovascular-related diagnosis or risk factor
- Has an appointment with Primary Care provider within 2 weeks of enrollment
Who cannot join
- Inadequate vision or hearing to complete on-line assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond Family Health Center at Oregon Health & Science University
Portland, Oregon, 97202
About this study
Official title: Beta Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Web-based Tool for Improving Communication Between Patients and Health Care Professionals
This research focuses on communication practices between patients and health care professionals, like nurses, doctors, or physician assistants. The goal is to help improve communication about heart health issues.
This pilot (or Beta) study is designed to test our ability to recruit an appropriate sample of participants, and determine our ability to deliver and evaluate the effects of a web-based intervention. The investigators hypothesize that exposure to the intervention will result in measurable changes in self-reported knowledge, attitudes and behavior regarding communication between patients and health care professionals.
Read more
Participants in this research study are being recruited from the people who currently receive care at the Richmond Family Health Center of the Oregon Health \& Science University. People who participate in this study will be between 55 and 70 years old, speak English as their preferred language, and have one of several possible diagnoses related to heart health. These could include, for example, hypertension, diabetes, asthma, or obesity.
Additionally, the investigators are recruiting a small number of health care professionals from the Richmond Family Health Center. Their participation will be similar to but separate from the participation of patients.
All participants will take two web-based surveys. Some participants will use a web-based tool that hopes to help improve communication between health care professionals and patients.
The surveys contain questions that explore the knowledge, attitudes, and behaviors of participants related to heart health and communication between health care professionals and patients.
Data analysis will focus upon identifying any changes that occurred in knowledge, attitudes, or behaviors with respect to health communication after using the web-based tool, as well as learning about what influences the quality and nature of communication between health care professionals and the patients they serve.
- Being tested
- Time to Talk CARDIO website
- Keywords
- Health communication, Health literacy, Patient, Health Care Professional, Satisfaction
- Medical subject headings
- Cardiovascular Diseases, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to Talk CARDIO websiteDevice
This interactive web-based training device involves the completion of a brief survey regarding communication experiences between patients and health care professionals. The pattern of responses to the survey generates a personalized set of short instructional videos which demonstrate effective communication skills.
| Study group | Role | What they receive |
|---|---|---|
| Web-based communication tool for health care professionals | Experimental | Not described Receives: Device: Time to Talk CARDIO website |
| Web-based communication training tool for patients | Experimental | Not described Receives: Device: Time to Talk CARDIO website |
| Usual care for patient participants | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal communication knowledge, attitudes and behaviors exhibeted by patients and health care professionals during a patient-provider office visit
Measured: 2 weeks
Secondary outcomes (4)
Patient and health care professional satisfaction with communication
Measured: 2 weeks
Change in patient average blood pressure
Measured: 6 months
Change in serum hemoglobin A1c value among patients with diabetes
Measured: 6 months
change in average appointment length for health care professionals
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cliff Coleman, Oregon Health and Science University
- Investigators
- Clifford A Coleman, MD, MPH, Principal investigator, Oregon Health and Science UniversityAndrew F Pleasant, Ph.D., Study director, Canyon Ranch Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983333
- Sponsor's protocol ID
- OHSU00005635
- Status last verified
- Oct 2015
- First submitted
- 23 Sep 2009
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Web-based Tool for Improving Communication Between Patients and Health Care Professionals
- ClinicalTrials.gov ID
- NCT00983333
- Acronym / sponsor ID
- OHSU00005635
- Keywords
- Health communication, Health literacy, Patient, Health Care Professional, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Sep 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.
This research focuses on communication practices between patients and health care professionals, like nurses, doctors, or physician assistants. The goal is to help improve communication about heart health issues.
This pilot (or Beta) study is designed to test our ability to recruit an appropriate sample of participants, and determine our ability to deliver and evaluate the effects of a web-based intervention. The investigators hypothesize that exposure to the intervention will result in measurable changes in self-reported knowledge, attitudes and behavior regarding communication between patients and health care professionals.
Participants in this research study are being recruited from the people who currently receive care at the Richmond Family Health Center of the Oregon Health \& Science University. People who participate in this study will be between 55 and 70 years old, speak English as their preferred language, and have one of several possible diagnoses related to heart health. These could include, for example, hypertension, diabetes, asthma, or obesity.
Additionally, the investigators are recruiting a small number of health care professionals from the Richmond Family Health Center. Their participation will be similar to but separate from the participation of patients.
All participants will take two web-based surveys. Some participants will use a web-based tool that hopes to help improve communication between health care professionals and patients.
The surveys contain questions that explore the knowledge, attitudes, and behaviors of participants related to heart health and communication between health care professionals and patients.
Data analysis will focus upon identifying any changes that occurred in knowledge, attitudes, or behaviors with respect to health communication after using the web-based tool, as well as learning about what influences the quality and nature of communication between health care professionals and the patients they serve.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Web-based communication tool for health care professionals | Experimental | Device: Time to Talk CARDIO website |
| Web-based communication training tool for patients | Experimental | Device: Time to Talk CARDIO website |
| Usual care for patient participants | No intervention | – |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55-70 years
- English is preferred language
- Has one or more chronic cardiovascular-related diagnosis or risk factor
- Has an appointment with Primary Care provider within 2 weeks of enrollment
Key exclusion criteria (1 listed)
- Inadequate vision or hearing to complete on-line assessment
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 |
|---|---|---|
| Time to Talk CARDIO websiteThis interactive web-based training device involves the completion of a brief survey regarding communication experiences between patients and health care professionals. The pattern of responses to the survey generates a personalized set of short instructional videos which demonstrate effective communication skills. | Device | Web-based communication tool for health care professionals, Web-based communication training tool for patients |
Primary outcome
Interpersonal communication knowledge, attitudes and behaviors exhibeted by patients and health care professionals during a patient-provider office visit
Time frame: 2 weeks
4 secondary outcomes
Patient and health care professional satisfaction with communication
Time frame: 2 weeks
Change in patient average blood pressure
Time frame: 6 months
Change in serum hemoglobin A1c value among patients with diabetes
Time frame: 6 months
change in average appointment length for health care professionals
Time frame: 6 months
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 16 Oct 2015.
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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.
Clifford A Coleman, MD, MPH principal investigator
Oregon Health and Science University
Andrew F Pleasant, Ph.D. study director
Canyon Ranch Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time to Talk CARDIO website in people with Cardiovascular Disease and Cardiovascular Risk Factors, run by Oregon Health and Science University 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 1 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 16 Oct 2015. 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?
Interpersonal communication knowledge, attitudes and behaviors exhibeted by patients and health care professionals during a patient-provider office visit (time frame: 2 weeks). 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 16 Oct 2015.