Efficacy of the Talking Health Together™ communication education intervention for primary care patients with chronic disease

ISRCTN	ISRCTN00745795
DOI	https://doi.org/10.1186/ISRCTN00745795
Protocol serial number	N/A
Sponsor	AstraZeneca Inc. (Canada)
Funder	AstraZeneca Inc. (Canada)

Submission date: 01/04/2009
Registration date: 27/05/2009
Last edited: 27/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marie-Therese Lussier
Scientific

4400 Earnscliffe
Montreal
H4A 3E8
Canada

Email	mtlussier@videotron.ca

Study information

Primary study design	Interventional
Study design	Prospective multicentre randomised three-arm parallel group study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	THT In Practice
Study objectives	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(s)	Institutional Review Board Services gave approval on the 9th January 2009
Health condition(s) or problem(s) studied	Type II diabetes mellitus, hypertension, hypercholesterolaemia
Intervention	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	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	06/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	360
Key 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.
Key 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
Date of first enrolment	15/03/2009
Date of final enrolment	06/07/2010

Locations

Countries of recruitment

Canada

Study participating centre

4400 Earnscliffe

Montreal
H4A 3E8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes