Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201505001097317 Date of Approval: 08/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title counselling and chronic conditions study
Official scientific title Strengthening mental health care in chronic care patients with hypertension. A cluster randomised control trial.
Brief summary describing the background and objectives of the trial Cardiovascular disease (coronary heart disease (CHD), hypertension and stroke) is the leading cause of mortality in the world and the second leading cause of death in Africa. Estimates by the World Health Organization using disability adjusted life years (DALYs) suggest that NCDs were responsible for 28% of the total burden of disease in South Africa in 2004, with heart disease, diabetes and stroke together being responsible for the second most important cause of death in adult South Africans. In our 2014 survey of three primary health care facilities in the North West Province where the Department of Health is piloting Integrated Chronic Disease Management (ICDM) we found that of the 1 250 chronic care patients surveyed, 51% reported having hypertension. Spurring the rising burden of NCDs are mental disorders. One in six adults experience a common mental disorder (depression, anxiety disorders and substance use disorders) within a 12 month period (Herman et al., 2009), yet only one in four receive treatment of any kind (Seedat et al., 2009). Depression in particular, co-exists with NCDs having a mutually reinforcing relationship compromising both prevention and treatment through exacerbating modifiable risk factors and compromising adherence and self-care respectively. Objectives: We propose to strengthen the Primary Care 101 (PC101) guidelines. This is a set of clinical guidelines and decision support for nurses developed for the identification and management of multiple chronic diseases. The strengthened PC101 will supplement the original 12 sessions of training with an additional four sessions focused exclusively on detecting and managing mental disorders and providing ongoing mentoring and supervision; strengthening the guidelines for stress identification and mental health first aid and identification and referral of depression and anxiety.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Depression, Hypertension,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 16/04/2015
Actual trial start date
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Counselling and chronic conditions study enhanced ususal primary health care, no specific psychosocial interventions 500 Active-Treatment of Control Group
Experimental Group conselling and chronic conditions study Weekly counselling sessions 8 weeks Facility-based stepped care intervention combining stress and depression case detection and management by non-physician clinicians and referral pathways for anti-depressant medication and/or group/individual counselling delivered by lay-health workers for patients with depression. 500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/03/2015 Biomedical Research Ethics Administration, UKZN
Ethics Committee Address
Street address City Postal code Country
UKZN, westville Campus, Govan Mbeki Building, Chiltern Hills Westville 3630 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of patients considered recovered from their depressive symptoms, as assessed using the PHQ-9 6 MONTHS
Secondary Outcome Blood pressure control 12 MONTHS
Secondary Outcome adherence using the self-reported Visual Analogue Scale 6 and 12 months
Secondary Outcome Perceived stress symptoms Baseline; 6 months; 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alabama Clinic 65 Alex street Klerksdorp 2577 South Africa
Boiki Thlapi CHC 4453 Rata Street, Ikageng Potchefstroom 2520 South Africa
Botshabelo CHC 5707 Lekomo Street, Ext 6 Stilfontein 2511 South Africa
Delekile Khoza Clinic 2405 Freedom Street, Ext 4 Hartbeesfontein 2600 South Africa
Empilisweni Clinic Morokapula Street Klerksdorp 2574 South Africa
JB Marks CHC 54 Carmichael Street Ventersdorp 2710 South Africa
Jouberton CHC Cnr Eigteenth and Ezibhedleleni Street Klerksdorp 2574 South Africa
Khuma Clinic Pop Molefe Road, Ext 8 Stilfontein 2551 South Africa
Leeudroingstad CHC 63 Smith Street Leeudoringstad 2640 South Africa
Lesego Clinic Maaroganye Street Ikageng, Potchefstroom South Africa
Marcus Zinzele Clinic 5810 Chris Hani Street Stilfontein 2251 South Africa
N Pretorius Gatew Clinic Mecury Street Klerksdorp 2574 South Africa
Park Street Clinic 40 Park Street Klerksdorp 2571 South Africa
Potchefstroom Clinic Cnr Gluckman and Sol Plaatjie Street Potchefstroom 2530 South Africa
Pomosa CHC Daisy Street Potchefstroom 2530 South Africa
S Tshwete Clinic Mogolodi Street Ext 7 Potchefstroom South Africa
Stilfontein Clinic Bloem Street Stilfontein South Africa
Tigan Clinic 204 Motsumi Street Tigan, Hartbeesfontein South Africa
Tsholofelo Clinic 439 Kopanong Street Jouberton 2571 South Africa
Tswelelelang 2 CHC 1365 Tamdo 4 Wolmaranstad South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Dept of International Development 22 Whitehall London SW1A2EG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DFID 22 Whitehall London SW1A2EG United Kingdom Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Lara R Fairall Knowledge Translation Unit, University of Cape Town Lung Institute Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Inge Petersen peterseni@ukzn.ac.za +27312607970 Mazisi Kunene Road, Glenwood
City Postal code Country Position/Affiliation
Durban 4041 South Africa Professor
Role Name Email Phone Street address
Public Enquiries Tasneem Kathree kathree@ukzn.ac.za +27312601700 Mazisi Kunene Road, Glenwood
City Postal code Country Position/Affiliation
Durban 4041 South Africa Research Coordinator
Role Name Email Phone Street address
Scientific Enquiries Inge Petersen peterseni@ukzn.ac.za +27312607970 Mazisi Kunene Road, Glenwood
City Postal code Country Position/Affiliation
Durban 4041 South Africa Professor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information