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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201505001097317 |
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Date of registration:
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08/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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counselling and chronic conditions study
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Scientific title:
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Strengthening mental health care in chronic care patients with hypertension. A cluster randomised control trial. |
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Date of first enrolment:
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16/04/2015 |
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Target sample size:
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1000 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1097 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,simple randomisation using a randomistiaon table created by a computer software program,Allocation was determined by the holder of the sequence who is situated off site
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Phase:
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Not Applicable
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Inge
Petersen |
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Address:
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Mazisi Kunene Road, Glenwood
4041
Durban
South Africa |
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Telephone:
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+27312607970 |
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Email:
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peterseni@ukzn.ac.za |
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Affiliation:
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Professor |
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Name:
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Tasneem
Kathree |
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Address:
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Mazisi Kunene Road, Glenwood
4041
Durban
South Africa |
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Telephone:
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+27312601700 |
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Email:
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kathree@ukzn.ac.za |
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Affiliation:
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Research Coordinator |
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Key inclusion & exclusion criteria
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Inclusion criteria: All adult chronic care patients 18 years or older receiving treatment for hypertension and with depressive symptoms, as indicated by a total score of 9 or more on the Patient Health Questionnaire 9(PHQ-9 who give valid consent.
20 largest eligible clinicsproviding chronic care according to ICDM (integrated chronic diseases management)model
Exclusion criteria: Clinics that do not provide ICDM; small (<10 000 attendances/ year); mobile or satellite
Individuals who plan to move away from the vicinity of the clinic in the next year, or do not manage an assessment based on a 3-item decisional capacity instrument developed to assess mental capacity consent
Age minimum:
18 Year(s)
Age maximum:
80 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Circulatory System
Mental and Behavioural Disorders
Depression, Hypertension
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Depression, Hypertension
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Circulatory System
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Mental and Behavioural Disorders
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Intervention(s)
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conselling and chronic conditions study
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Counselling and chronic conditions study
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Primary Outcome(s)
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Proportion of patients considered recovered from their depressive symptoms, as assessed using the PHQ-9
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Secondary Outcome(s)
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adherence using the self-reported Visual Analogue Scale
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Blood pressure control
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Perceived stress symptoms
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Source(s) of Monetary Support
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Dept of International Development
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Ethics review
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Status: Approved
Approval date: 26/03/2015
Contact:
Biomedical Research Ethics Administration, UKZN
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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