Condition category
Eye Diseases
Date applied
03/12/2012
Date assigned
30/01/2013
Last edited
30/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohammed Mahdi Abdull

ORCID ID

Contact details

International Centre for Eye Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E7HT
United Kingdom
+44 (0)7544706291
mohammed.abdull@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.2

Study information

Scientific title

Randomised controlled trial of adapted motivational interviewing for acceptance and adherence to treatment in glaucoma patients in Bauchi

Acronym

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.

On 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 anticipated start date was changed from 15/01/2013 to 01/09/2013.
4. The anticipated end date was changed from 15/07/2014 to 01/12/2015.
5. The target number of participants was changed from 400 to 300.

Ethics approval

Added 16/09/2013:
1. London School of Hygiene and Tropical Medicine, ref: 6464, 17/07/2013
2. Abubakar Tafawa Balewa University Teaching Hospital, ref: ATBUTH/ADM/42/VOL1, 22/08/2013

Study design

Randomised controlled double blind single site trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Glaucoma is a progressive optic neuropathy involving characteristic structural damage to the optic nerve with characteristic visual field defects.

Intervention

Current interventions as of 16/09/2013:

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 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:

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 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2013

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

01/09/2013

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Nigeria

Trial participating centre

International Centre for Eye Health
London
WC1E7HT
United Kingdom

Sponsor information

Organisation

International Centre for Eye Health (UK)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.lshtm.ac.uk

Funders

Funder type

Research council

Funder name

British Council for Prevention of Blindness (UK) ref: ITCR BH 5810

Alternative name(s)

BCPB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24773760

Publication citations

  1. Protocol

    Abdull MM, Gilbert C, McCambridge J, Evans J, Adapted motivational interviewing to improve the uptake of treatment for glaucoma in Nigeria: study protocol for a randomized controlled trial., Trials, 2014, 15, 149, doi: 10.1186/1745-6215-15-149.

Additional files

Editorial Notes