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
Secondary identifying numbers N/A
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

Study designProspective multicentre randomised three-arm parallel group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 acronymTHT In Practice
Study objectivesWe 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) studiedType II diabetes mellitus, hypertension, hypercholesterolaemia
InterventionThe 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 typeOther
Primary outcome measureEvaluate 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 measures1. 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 study start date15/03/2009
Completion date06/07/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants360
Key inclusion criteriaTo 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 criteria1. 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 enrolment15/03/2009
Date of final enrolment06/07/2010

Locations

Countries of recruitment

  • Canada

Study participating centre

4400 Earnscliffe
Montreal
H4A 3E8
Canada

Sponsor information

AstraZeneca Inc. (Canada)
Industry

c/o Duncan Jewell
1004 Middlegate Road
Mississauga
L4Y 1M4
Canada

Email duncan.jewell@astrazeneca.com
Website http://www.astrazeneca.com/
ROR logo "ROR" https://ror.org/04n8fbz89

Funders

Funder type

Industry

AstraZeneca Inc. (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan