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

Completed

• Conditions: Type II diabetes mellitus, hypertension, hypercholesterolaemia; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN00745795
• Lead Sponsor: AstraZeneca Inc. (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified