Plain English Summary
Background and study aims
Making sure major depressive disorder (MDD) patients take their antidepressant treatment (adherence to medication) is essential in managing their condition. Adherence to medication is a dynamic decision-making process, and pharmacists play an important role in improving adherence to antidepressant treatment in different settings within the health care system. Shared decision making (SDM) is a conversation between a patient and a healthcare professional whereby decisions are made about a patients treatment, taking into account what is important to both parties. Here, we want to test a pharmacist intervention (programme) based on SDM to see whether it improves adherence to medication and, ultimately, how successful the treatment is at treating MDD.
Who can participate?
Adults (aged between 18-60) newly diagnosed with MDD.
What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 (intervention group) attend a SDM session with a pharmacist which focused on improving the patients involvement in decision making, their beliefs towards antidepressants and their knowledge about antidepressants. Those in group 2 do not attend a SDM session. Adherence to medication, severity of depression, health-related quality of life, patient satisfaction and the patients beliefs about medicine is assessed for all participants at the start of the study, 3 months after the study begins and then again at 6 months.
What are the possible benefits and risks of participating?
The study was designed to minimize any potential risks to the patients. Participants may benefit from intervention conducted in this study.
Where is the study run from?
Al Amal Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
February 2014 to July 2014
Who is funding the study?
Investigator initiated and funded (Saudi Arabia)
Who is the main contact?
Khalaf Aljumah
khalafaljumaah@yahoo.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Impact of pharmacist interventions on adherence and measurable patient outcomes among depressed patients: a randomised controlled study
Acronym
Study hypothesis
The evidence relating to patients’ active participation in depression treatment decision making supports the hypothesis that this will result in improved adherence, satisfaction, and improved clinical outcomes.
Ethics approval
AM2013-12
Study design
Interventional prospective randomised controlled study with a 6-month follow-up
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patients diagnosed with major depression disorders
Intervention
The intervention focused on the enhancement of the patients’ involvement in decision making, their beliefs towards antidepressants and their knowledge about antidepressants.
Pharmacists followed the SDM competency framework proposed by Simmons et al, which was designed specifically for depressed patients, to ensure the coverage of all aspects of SDM for each patient. Before the SDM session started, the research team distributed a decision aid, which was developed and validated by Aljumah et al. and was specified for Arabic-speaking patients, to patients in the intervention group (IG). The intervention focused on the enhancement of the patients’ involvement in decision making, their beliefs towards antidepressants and their knowledge about antidepressants. The average time for the first SDM session (at baseline) was 15 minutes and 10 minutes for the remaining SDM sessions.
Randomisation:
A simple randomisation process was used. Study participants were individually randomised to one of two parallel groups with an allocation ratio of 1:1 using a computer-generated list. The computer-generated allocation was done by a research assistant with no clinical involvement in the trial. Pharmacists and psychiatrists were not blinded to the patients’ distribution between groups. The research assistant who collected all the data was blinded to the distribution of patients
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Adherence measured by Medication Adherence Scale (MMAS) at baseline, 3 months and 6 months
Secondary outcome measures
1. Patients’ beliefs about medicine measured by Beliefs About Medicine Questionnaire (BMQ)
2. Severity of depression measured by MADRS scale
3. Patients’ involvement in decisions
4. Health-related quality of life - measured by EuroQOL-5D
5. Patient satisfaction with treatment
Measured at baseline, 3 months and 6 months.
Overall trial start date
10/02/2014
Overall trial end date
29/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients within the age range of 18 to 60 years
2. Patients newly diagnosed with a MDD, according to the scales in the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed (DSM-IV)
3. Patients having no psychotic or bipolar history
4. Patients having no drug or dependency history
5. Patients having no cognitive impairment that may hinder the assessment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
195 patients
Participant exclusion criteria
1. Patients having a psychiatric or bipolar disorder history
2. Patients having drug or dependency history.
3. Patients suffering from any cognitive impairment that may hinder the assessment
4. Patients not responding at any level to the antidepressant within 8 weeks of recruitment
Recruitment start date
10/02/2014
Recruitment end date
29/07/2014
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
Al Amal Hospital
Shobah
PO box 87904
Riyadh
11652
Saudi Arabia
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Saudi Arabia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26376830