ISRCTN79330571 - Will counselling using a modification of motivational interviewing method improve the acceptance of surgery and adherence to treatment and follow up in glaucoma patients in Bauchi?

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21 March 2013

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Will counselling using a modification of motivational interviewing method improve the acceptance of surgery and adherence to treatment and follow up in glaucoma patients in Bauchi?

ISRCTN	ISRCTN79330571
DOI	10.1186/ISRCTN79330571
ClinicalTrials.gov identifier
EudraCT number
Public title	Will counselling using a modification of motivational interviewing method improve the acceptance of surgery and adherence to treatment and follow up in glaucoma patients in Bauchi?
Scientific title	Randomised controlled trial of modified motivational interviewing for acceptance and adherence to treatment in glaucoma patients in Bauchi
Acronym	N/A
Serial number at source	N/A
Study hypothesis	Patient counselling delivered using adapted motivational interview by a trained interviewer increases rates of surgery among glaucoma patients where this is the treatment of choice, as well as short term follow up and control of intraocular pressure (IOP). Also that adapted motivational interview will improve adherence to topical glaucoma therapy and short term follow up and control of IOP among those who reject surgery.
Lay summary	Background and study aims Glaucoma causes irreversible blindness in 4.6 to 6.7 million people worldwide. In Nigeria, the frequency (or prevalence) of blindness in adults 40 years and above is 4.2%, 16.3% due to glaucoma. Glaucoma is a blinding eye disease that has several forms. The commonest form in Africa causes progressive, painless loss of the peripheral field of vision. Eventually central vision is lost too and the eye/person becomes totally blind. The blindness is irreversible. The only current treatment is to lower the pressure of the eye and this can be done by the use of eye drops, surgery or laser treatment. As with all chronic or lifelong diseases, glaucoma needs to be managed and followed up needs to be for life. There are several reasons why glaucoma control is a major challenge in Africa. 1. The following factors lead to late presentation: a. Earlier age of onset of the disease - aggressive course; b. Lack of early symptoms as loss of vision is painless; c. Lack of a single, simple, valid screening test; d. Lack of awareness; e. Lack of primary eye care 2. The following factors impede optimal management once patients present: a. We are not sure whether topical medication or surgery works better in case of advanced disease; b. Poor uptake of surgical treatment; c. Lack of adherence to medical treatment; d. Lack of adherence to or poor follow up. Motivational interviewing (MI) is a form of counselling designed to strengthen personal motivation for and commitment to a specific goal by eliciting and exploring the persons� own reasons for change within an atmosphere of acceptance and compassion. There is evidence that it can work in psychiatry, substance abuse, HIV care, smoking cessation, healthy life style changes and in other fields of medical and health care. Motivational interview is a skill that can be taught at most levels. Studies have shown that paraprofessionals can be trained in MI with good results. The aim of this study is to assess whether a locally adapted motivational interviewing session about glaucoma and its treatment, has an effect on the management of glaucoma in Bauchi state, Nigeria. Who can participate? Glaucoma patients attending the eye clinic at Abubakar Tafawa Balewa University Teaching Hospital in Bauchi, Nigeria. Participants have to live within 200 km of the study site. What does the study involve? The study involves glaucoma patients assigned at random to either having a 30-40 minutes interview/discussion or not with one of 2 interviewers who are also assigned at random. What are the possible benefits and risks of participating? Possible benefit of participating is for the patient to get more information about glaucoma that will motivate him/her to make the right decisions regarding treatment to prevent avoidable blindness. There may be emotional pressure on some patients to try to adhere to treatment. Where is the study run from? The study is run from the London school of Hygiene and Tropical medicine, but the principal investigator will be at the study site as the attending ophthalmologist seeing the patients (eye clinic at Abubakar Tafawa Balewa University Teaching Hospital in Bauchi, Nigeria). When is the study starting and how long is it expected to run for? The study is expected to start by 15the January 2013 and run for one and a half year or until the total number of participants needed (400) have been recruited and their follow-up is completed. Who is funding the study? The study is being funded by the British Council for Prevention of Blindness. Who is the main contact? Dr Mohammed Mahdi Abdull, mohammed.abdull@lshtm.ac.uk OR Dr Mohammed Mahdi Abdull Ophthalmology Department Abubakar Tafawa Balewa University Teaching Hospital PMB 0117 Bauchi Bauchi State Nigeria
Ethics approval	Not provided at the time of registration
Study design	Randomised controlled double blind single site trial
Countries of recruitment	Nigeria
Disease/condition/study domain	Glaucoma is a progressive optic neuropathy involving characteristic structural damage to the optic nerve with characteristic visual field defects.
Participants - inclusion criteria	1. Primary open angle glaucoma in at least one eye, where surgery or LASER is the treatment of choice in one or both eyes. 2. Aged 17 years or more (can give consent) 3. Residence within 200km of Bauchi, the study site 4. Understands and speaks Hausa or English 5. Informed consent
Participants - exclusion criteria	1. Other forms of treatment other than surgery or LASER more appropriate 2. Other ocular pathology except cataract. 3. Systemic diseases/problems that contraindicate surgery
Anticipated start date	15/01/2013
Anticipated end date	15/07/2014
Status of trial	Ongoing
Patient information material	Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants	400
Interventions	Glaucoma is a progressive optic neuropathy involving characteristic structural damage to the optic nerve with characteristic visual field defects. In glaucoma there is progressive constriction of this field of vision until eventually it is extinguished leading to complete and irreversible blindness. Risk Factors for POAG. These include raised IOP, increasing age, African Caribbean origin, and family history, Myopia, thin central corneal thickness, Treatment of Glaucoma Intraocular pressure is the only modifiable risk factor for glaucoma. Adequate lowering of IOP controls the disease. Many different treatment modalities exist. These include eye drops for life, surgery: (trabeculectomy with or without antiscarring agents), shunts and artificial drainage devices LASER treatment, Neuroprotective agents, etc. The intervention is one to 3 sessions of adapted motivational interview to patients allocated at random. Patients allocated will be interviewed alone or with their carer or household head. The interview will be conducted by one of two trained interviewers also allocated at random. It will not be guided by a manual but the interviewer will have full knowledge of the adapted motivational interview package developed.
Primary outcome measure(s)	Proportion of participants who attend for and/or undergo surgery in the study eye, within 4 months of being listed for glaucoma surgery
Secondary outcome measure(s)	1. Accept surgery within 4 months: 1.1. Proportion of participants who report for follow up at 1, 2, 4 and 6 months following surgery 1.2. Proportion of participants whose IOP is controlled at 1, 2, 4 and 6 months (<20 mmHg in the study eye) 2. Refuse surgery after 4 months: 2.1. Proportion of participants who adhere to medical treatments at each follow up 2.2. Proportion of participants whose IOP is controlled at 1, 2, 4 and 6 months (<20 mmHg in the study eye)
Sources of funding	British Council for Prevention of Blindness (UK) ref: ITCR BH 5810
Trial website
Publications
Contact name	Dr Mohammed Mahdi Abdull
Address	International Centre for Eye Health London School of Hygiene and Tropical Medicine Keppel Street
City/town	London
Zip/Postcode	WC1E7HT
Country	United Kingdom
Tel	+44 (0)7544706291
Email	mohammed.abdull@lshtm.ac.uk
Sponsor	International Centre for Eye Health (UK)
Address	London School of Hygiene and Tropical Medicine Keppel Street
City/town	London
Zip/Postcode	WC1E 7HT
Country	United Kingdom
Sponsor website:	http://www.lshtm.ac.uk
Date applied	03/12/2012
Last edited	30/01/2013
Date ISRCTN assigned	30/01/2013


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