Will counselling using an adaptation of motivational interviewing method improve the acceptance of surgery and adherence to treatment and follow up in among glaucoma patients in Bauchi

ISRCTN	ISRCTN79330571
DOI	https://doi.org/10.1186/ISRCTN79330571
Secondary identifying numbers	Version 1.2

Submission date: 03/12/2012
Registration date: 30/01/2013
Last edited: 22/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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?
Participants are randomly allocated to either having a 30-40 minutes interview/discussion or not with one of two interviewers who are also assigned at random.

What are the possible benefits and risks of participating?
The 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?
September 2013 to December 2015

Who is funding the study?
The British Council for Prevention of Blindness (UK)

Who is the main contact?
Dr Mohammed Mahdi Abdull
mohammed.abdull@lshtm.ac.uk

Contact information

Dr Mohammed Mahdi Abdull
Scientific

International Centre for Eye Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E7HT
United Kingdom

Phone	+44 (0)7544706291
Email	mohammed.abdull@lshtm.ac.uk

Study information

Study design	Randomised controlled double-blind single-site trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Randomised controlled trial of adapted motivational interviewing for acceptance and adherence to treatment in glaucoma patients in Bauchi
Study objectives	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.
Ethics approval(s)	1. London School of Hygiene and Tropical Medicine, 17/07/2013, ref: 6464 2. Abubakar Tafawa Balewa University Teaching Hospital, 22/08/2013, ref: ATBUTH/ADM/42/VOL1
Health condition(s) or problem(s) studied	Glaucoma
Intervention	Current interventions as of 16/09/2013: The intervention is one to two 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. Previous interventions: The intervention is one to three 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.
Intervention type	Other
Primary outcome measure	Current primary outcome measures as of 16/09/2013: Proportion of participants who attend for and/or undergo surgery in the study eye, within 2 months of being listed for glaucoma surgery Previous primary outcome measures: 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 measures	Current secondary outcome measures as of 16/09/2013: 1. Accept surgery within 2 months:   1.1. Proportion of participants who report for follow up at 1, 6 and 12 months following surgery 1.2. Proportion of participants whose IOP is controlled at 1, 6 and 12 months (<20 mmHg in the study eye) 2. Refuse surgery after 2 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, 6 and 12 months (<20 mmHg in the study eye) Previous secondary outcome measures: 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)
Overall study start date	01/09/2013
Completion date	01/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	300
Key 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
Key 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
Date of first enrolment	01/09/2013
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

England
Nigeria
United Kingdom

Study participating centre

International Centre for Eye Health

London
WC1E7HT
United Kingdom

Sponsor information

International Centre for Eye Health (UK)
Research organisation

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Website	http://www.lshtm.ac.uk
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Research council

British Council for Prevention of Blindness (UK) ref: ITCR BH 5810
Private sector organisation / Other non-profit organizations

Alternative name(s): BCPB
Location: United Kingdom

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	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/04/2014		Yes	No
Results article	results	29/04/2014	22/01/2019	Yes	No

Editorial Notes

22/01/2019: Publication reference added
16/09/2013: The following changes were made to the trial record:
1. The public title was changed from "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?" to "Will counselling using an adaptation of motivational interviewing method improve the acceptance of surgery and adherence to treatment and follow up in among glaucoma patients in Bauchi".
2. The scientific title was changed from "Randomised controlled trial of modified motivational interviewing for acceptance and adherence to treatment in glaucoma patients in Bauchi" to "Randomised controlled trial of adapted motivational interviewing for acceptance and adherence to treatment in glaucoma patients in Bauchi".
3. The overall trial start date was changed from 15/01/2013 to 01/09/2013.
4. The overall trial end date was changed from 15/07/2014 to 01/12/2015.
5. The target number of participants was changed from 400 to 300.