Integration of mental health in primary care in Kenya

ISRCTN	ISRCTN53515024
DOI	https://doi.org/10.1186/ISRCTN53515024
Secondary identifying numbers	N/A

Submission date: 03/11/2011
Registration date: 14/11/2011
Last edited: 07/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The study aims to measure whether a 40 hour mental health structured and standardised training course for front line health workers in Kenya can help them diagnose mental health problems better and facilitate the recovery of their clients over a three month follow up period.

Who can participate?
Men and women aged over 16 are eligible to participate in the study. People with learning disabilities, dementia and life threatening illness are excluded.

What does the study involve?
The study compares health workers and their clients from 50 health centres where staff have received the mental health training with health workers and their clients from 50 health centres where staff have not received the mental health training.
All clients receive their normal care from the health workers; the study is not testing a specific drug.

What are the possible benefits and risks of participating?
Participation in the study will enable researchers and health personnel to better understand the health needs of clients and the training needs of those who care for them. There are no personal rewards for participation but participants may benefit by understanding mental health care better.

Where is the study run from?
The study is run from Great Lakes University Kisumu, University of Nairobi and Kings College London. There are 100 health centres involved in Nyanza province.

When is the study starting and how long is it expected to run for?
The study is running between August 2010 and December 2011. Participants have already been recruited.

Who is funding the study?
UK Department for International Development and the Nuffield Foundation.

Who is the main contact?
Professor Rachel Jenkins, Kings College London

Contact information

Prof Rachel Jenkins
Scientific

Health Services Research Department
Instuitute of Psychiatry
King's College London
de Crespigny Park
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0668
Email	rachel@olan.org

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Assessment of the impact of a Kenya Medical training College delivered structured five day training programme on mental health core concepts, skills and competencies on mental health for primary care staff in Kenya
Study objectives	The training programme will have an impact on: 1.The competencies of primary care staff to recognise mental disorders and 2. On recovery (improved health and social outcomes and quality of life of clients)
Ethics approval(s)	1. King's College London Ethics Committee approved on 5th October 2009, ref: PNM/08/09-113 2. University of Nairobi Ethics Committee approved on 15th October 2009, ref: P53/02/2009 3. Great Lakes University Kisumu Ethics Committee approved on 1st April 2010, ref: GERC/002/2010
Health condition(s) or problem(s) studied	Mental health
Intervention	100 primary care centres randomly allocated to intervention and control arms. The health workers' ability to diagnose and the clients' recovery was assessed All patients attending this clinic will be asked to undergo a brief general health questionnaire which takes less than five minutes to complete. Twelve patients selected at random will then also be asked to complete a set of more detailed questionnaires. These will be completed twice, once now and once more in ten weeks time. Training course for health workers. Intervention arm received 40 hours of training comprising 5 units, (1) core concepts, (2) core skills, (3) common neurological disorders (4) mental disorders, (5) policy, legislation, human rights, Health Management Information System (HMIS), community linkages, roles and responsibilities. Teaching structured into 30 minute modules, each containing a short lecture, discussion and a role play. Both arms were able to attend other health training courses as normal throughout the period of the study
Intervention type	Other
Primary outcome measure	Patient identification index measured 3 months post training
Secondary outcome measures	1. Client recovery in terms of change on: 1.1. General health Questionnaire 1.2. World Health Organization Disability Assessment Schedule (WHODAS) and 1.3. EQ5D (Quality of LIfe) Assessed by change between status at 3 months and status at 6 months after the training of the health workers
Overall study start date	01/08/2010
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1200 clients and 100 health workers
Key inclusion criteria	Clinics: Is that they are publicly funded and on the Ministry of Health list of primary care centres. Patients: 1. Is that they have attended the clinic on the research day 2. That they are over 16
Key exclusion criteria	1. Dementia and learning disability of such severity as to be unable to complete the questionnaires 2. Life threatening illness 3. Don't speak the languages spoken by the researchers 4. Refusal to consent
Date of first enrolment	01/08/2010
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

England
Kenya
United Kingdom

Study participating centre

Health Services Research Department

London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

de Crespigny Park
London
SE5 8AF
England
United Kingdom

Phone	+44 (0)20 7848 0668
Email	rachel.jenkins@kcl.ac.uk
Website	http://kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Government

Nuffield Foundation and Department for International Development (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	client results	23/01/2013	Yes	No
Results article	health worker results	04/02/2013	Yes	No
Results article	results	30/09/2013	Yes	No
Results article	results	05/11/2013	Yes	No