Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Marie-Therese Lussier


Contact details

4400 Earnscliffe
H4A 3E8

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A multicentre, randomised trial in Ontario to evaluate the efficacy of Talking Health Together™ (THT in Practice), a communication education intervention for primary care patients with chronic disease


THT In Practice

Study hypothesis

We hypothesise that both Prepare, Ask, Check and Express (PACE) Talking Health Together™ (THT) education approaches compared to usual care will improve patient participation in medical encounters with their primary care physician. We also hypothesise that the combined THT e-Learning followed by workshop approach compared to the THT e-Learning alone approach will be more efficacious in improving patient participation in medical encounters.

Ethics approval

Institutional Review Board Services gave approval on the 9th January 2009

Study design

Prospective multicentre randomised three-arm parallel group study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Type II diabetes mellitus, hypertension, hypercholesterolaemia


The three intervention arms are as follows:
1. THT e-Learning module alone
2. THT e-Learning module followed by THT nurse-led workshop
3. Control Group - wsual care (no THT intervention or other intervention)

Total duration of treatment is the length of time it takes to complete the on-line training for the e-Learning arm (approximately 45 minutes to 1 hour) and the length of time it takes to do the workshop (approximately 3 hours). For the third arm that gets usual care, there is no intervention.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Evaluate the impact, compared to usual care, of a PACE training intervention of patients with chronic disease using one of two THT education approaches (either e-Learning only or e-Learning followed by a workshop) on patients' participation in primary care encounters assessed after intervention. We also will compare the impact of the THT e-Learning only approach to the THT e-Learning followed by workshop approach in the same way. This will be assessed by coding and analysis of audio-taped dialogue between the patient and the doctor at second of two doctor visits. Two published methodologies will be used: RIAS and MEDICODE.

Secondary outcome measures

1. Physician satisfaction with the doctor-patient encounter
2. Physician sense of partnership with patients
3. Patient perception of quality of doctor-patient communication and relationship
4. Patient confidence in own ability to communicate effectively with their doctor
5. Patient perception of the management of their chronic disease(s)
6. Patient recall of discussions of lifestyle recommendations and chronic disease medications discussed during the encounter

Assessed by questionnaires filled out by both patients and physicians at both visit 1 and visit 2.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

To be eligible to participate in the study, male or female patients of participating physicians must:
1. Be aged 40 years of age or greater
2. Have clinical documentation of diagnosis of at least one of the following pharmacologically-treated chronic conditions for which standard disease measures are considered to not be to target:
2.1. Type II diabetes mellitus as defined by the Canadian Diabetes Association Clinical Practice Guidelines (haemoglobin A1C greater than 7.0)
2.2. Hypertension defined as either resting office diastolic blood pressure of greater than 90 mmHg or resting office systolic blood pressure of greater than 140 mmHg and for diabetics: either resting office diastolic blood pressure of greater than 80 mmHg or resting office systolic blood pressure of greater than 130 mmHg as per Canadian Hypertension Education Program (CHEP) Guidelines
2.3. Hypercholesterolaemia as defined by the Hyperlipidaemia Canadian Consensus Guidelines (Low risk patients: low density lipoprotein [LDL] greater than or equal to 5.0 mmol/l or total cholesterol [TC]/high density lipoprotein [HDL] greater than or equal to 6 mmol/l, and high risk patients: LDL greater than 2 mmol/l or TC/HDL greater than 4 mmol/l)
3. Receive a prescribed medication for the chronic disease for which they were included in the study (i.e., hypertension, diabetes and hypercholesterolaemia)
4. Fill their prescriptions for the chronic disease for which they were included in the study at a pharmacy where the prescription information is available in the RxCanada® Inc. database
5. Have a routine clinic follow-up visit scheduled within three to six months of study enrolment

All participating patients will complete an informed consent form before initiation of any study related procedures.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patients in the active phase of cancer treatment (i.e. chemotherapy or radiotherapy at time of this study)
2. Previous enrolment in the present study
3. Pregnant or lactating women
4. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
5. Involvement in any other clinical study or adherence program
6. Inability to read or write in English
7. Inability to carry out the encounter with their physician in English without need of assistance
8. Uncomfortable using a computer for routine activities such as regular access to the web and e-mail

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

4400 Earnscliffe
H4A 3E8

Sponsor information


AstraZeneca Inc. (Canada)

Sponsor details

c/o Duncan Jewell
1004 Middlegate Road
L4Y 1M4

Sponsor type




Funder type


Funder name

AstraZeneca Inc. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes