A Study of the Effect of Patient Education (Talking Health Together) in Improving Doctor-patient Communication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00879736
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : August 22, 2011
Dr. Marie-Therese Lussier
Dr. Claude Richard
Information provided by:

Brief 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. 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.

Condition or disease Intervention/treatment
Doctor-patient Communication Improvement Behavioral: THT PACE Training Other: placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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.
Study Start Date : March 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: THT PACE eLearning module
The PACE (prepare, ask, check, express) training methodology will be available to patients before their 2nd doctor visit
Behavioral: THT PACE Training
Patient training
Active Comparator: THT PACE eLearning module & nurse-led workshop training
THT PACE eLearning and then nurse-led workshop for training on PACE methodology
Behavioral: THT PACE Training
Patient training
Placebo Comparator: Usual care
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
Other: placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. physician satisfaction and sense of partnership with the doctor-patient encounter;
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00879736

Canada, Ontario
Research Site
Burlington, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kitchener-Waterloo, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Oakville, Ontario, Canada
Sponsors and Collaborators
Dr. Marie-Therese Lussier
Dr. Claude Richard
Principal Investigator: Dr. Marie-Thérèse Lussier, MD, BSc., MSc., FCMFC Université de Montréal

Responsible Party: AstraZeneca, Astrazeneca Identifier: NCT00879736     History of Changes
Other Study ID Numbers: THT in practice
First Posted: April 10, 2009    Key Record Dates
Last Update Posted: August 22, 2011
Last Verified: October 2010

Keywords provided by AstraZeneca:
Doctor-patient communication
Patient education training