Doctor-patient Communication ImprovementNCT00879736
A Study of the Effect of Patient Education (Talking Health Together) in Improving Doctor-patient Communication
A study testing THT PACE Training in people with Doctor-patient Communication Improvement, run by AstraZeneca at 5 sites in Canada.
Trial summary
This study is being carried out to see if patients make the lifestyle changes or take their medication as instructed by their doctor during their visit as a result of the T.H.T. patient-education training. Proper information exchange between doctors and patients is an important part of quality health care. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Doctor-patient Communication Improvement
- What is being tested?
- THT PACE Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 5 sitesCanada
- Study dates
- Mar 2009to Aug 2010
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 40 years of age or greater
- Clinical documentation of diagnosis not to target of at least one of the following: Type II Diabetes Mellitus, Hypertension or Hypercholesterolemia
- Receive a prescribed medication for the chronic disease for which they were included in the study
Who cannot join
- Patients in active phase of cancer treatment (i.e. chemotherapy or radiotherapy at time of study).
- Inability to carry out the encounter with their physician in English without need of assistance
- Uncomfortable using a computer for routine activities such as regular access to the web and e-mail.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Research Site
Burlington, Ontario
Research Site
Hamilton, Ontario
Research Site
Kitchener-Waterloo, Ontario
Research Site
Mississauga, Ontario
Research Site
Oakville, Ontario
About this study
Official title: A Multi-centre, Randomised Trial in Ontario to Evaluate the Efficacy of Talking Health Together T.M. (T.H.T. in Practice), a Communication Education Intervention for Primary Care Patients With Chronic Disease.
This study is being carried out to see if patients make the lifestyle changes or take their medication as instructed by their doctor during their visit as a result of the T.H.T. patient-education training. Proper information exchange between doctors and patients is an important part of quality health care. Although many patients would like more information, they often do not ask for it directly during doctor-patient visits. The patient-training in this study specifically aims at improving patient participation during medical appointments by building communication skills such as requests for information and sharing health concerns with the doctor.
- Conditions
- Doctor-patient Communication Improvement
- Being tested
- THT PACE Training, placebo
- Keywords
- Doctor-patient communication, Encounters, Patient education training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THT PACE TrainingBehavioural
Patient training
THT PACE TrainingBehavioural
Patient training
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| THT PACE eLearning module | Active comparator | The PACE (prepare, ask, check, express) training methodology will be available to patients before their 2nd doctor visit Receives: Behavioral: THT PACE Training |
| THT PACE eLearning module & nurse-led workshop training | Active comparator | THT PACE eLearning and then nurse-led workshop for training on PACE methodology Receives: Behavioral: THT PACE Training |
| Usual care | Placebo comparator | Patients just go to their doctor as they normally would but get some disease specific information in the form of brochures as do intervention arms Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact, compared to Usual Care, of training interventions on patients with chronic disease on patient participation in primary care encounters assessed after intervention.
Measured: once
Secondary outcomes (3)
physician satisfaction and sense of partnership with the doctor-patient encounter;
patient perception of quality of doctor-patient communication and relationship and patient confidence in own ability to communicate effectively with their doctor;
Measured: Twice
patient perception of the management of their chronic disease(s); and patient recall of discussions of lifestyle recommendations and chronic disease medications discussed during the encounter.
Measured: Twice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doctor-patient Communication ImprovementStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Marie-Therese Lussier, Dr. Claude Richard
- Investigators
- Dr. Marie-Thérèse Lussier, MD, BSc., MSc., FCMFC, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879736
- Sponsor's protocol ID
- THT in practice
- Status last verified
- Oct 2010
- First submitted
- 8 Apr 2009
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised Trial in Ontario to Evaluate the Efficacy of Talking Health Together T.M. (T.H.T. in Practice), a Communication Education Intervention for Primary Care Patients With Chronic Disease.
- ClinicalTrials.gov ID
- NCT00879736
- Acronym / sponsor ID
- THT in practice
- Conditions
- Doctor-patient Communication Improvement
- Keywords
- Doctor-patient communication, Encounters, Patient education training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Marie-Therese Lussier, Dr. Claude Richard
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Apr 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 study is being carried out to see if patients make the lifestyle changes or take their medication as instructed by their doctor during their visit as a result of the T.H.T. patient-education training. Proper information exchange between doctors and patients is an important part of quality health care. Although many patients would like more information, they often do not ask for it directly during doctor-patient visits. The patient-training in this study specifically aims at improving patient participation during medical appointments by building communication skills such as requests for information and sharing health concerns with the doctor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THT PACE eLearning module | Active comparator | Behavioral: THT PACE TrainingThe PACE (prepare, ask, check, express) training methodology will be available to patients before their 2nd doctor visit |
| THT PACE eLearning module & nurse-led workshop training | Active comparator | Behavioral: THT PACE TrainingTHT PACE eLearning and then nurse-led workshop for training on PACE methodology |
| Usual care | Placebo comparator | Other: placeboPatients just go to their doctor as they normally would but get some disease specific information in the form of brochures as do intervention arms |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged 40 years of age or greater
- Clinical documentation of diagnosis not to target of at least one of the following: Type II Diabetes Mellitus, Hypertension or Hypercholesterolemia
- Receive a prescribed medication for the chronic disease for which they were included in the study
Key exclusion criteria (3 listed)
- Patients in active phase of cancer treatment (i.e. chemotherapy or radiotherapy at time of study).
- Inability to carry out the encounter with their physician in English without need of assistance
- Uncomfortable using a computer for routine activities such as regular access to the web and e-mail.
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 |
|---|---|---|
| THT PACE TrainingPatient training | Behavioural | THT PACE eLearning module |
| THT PACE TrainingPatient training | Behavioural | THT PACE eLearning module & nurse-led workshop training |
| placebo | Other | Usual care |
Primary outcome
To evaluate the impact, compared to Usual Care, of training interventions on patients with chronic disease on patient participation in primary care encounters assessed after intervention.
Time frame: once
3 secondary outcomes
physician satisfaction and sense of partnership with the doctor-patient encounter;
patient perception of quality of doctor-patient communication and relationship and patient confidence in own ability to communicate effectively with their doctor;
Time frame: Twice
patient perception of the management of their chronic disease(s); and patient recall of discussions of lifestyle recommendations and chronic disease medications discussed during the encounter.
Time frame: Twice
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 22 Aug 2011.
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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.
Dr. Marie-Thérèse Lussier, MD, BSc., MSc., FCMFC principal investigator
Université de Montréal
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THT PACE Training in people with Doctor-patient Communication Improvement, run by AstraZeneca at 5 sites in Canada.
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 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
To evaluate the impact, compared to Usual Care, of training interventions on patients with chronic disease on patient participation in primary care encounters assessed after intervention. (time frame: once). 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 22 Aug 2011.