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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00745795
Enrollment
360
Registered
2009-05-27
Start date
2009-03-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II diabetes mellitus, hypertension, hypercholesterolaemia Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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 inter

Sponsors

AstraZeneca Inc. (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026