Condition category
Mental and Behavioural Disorders
Date applied
22/11/2014
Date assigned
30/12/2014
Last edited
22/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Khalaf Aljumah

ORCID ID

Contact details

P.O.Box 33626 ‎
Riyadh
11458‎
Saudi Arabia

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 measures

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

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

Sponsor information

Organisation

Al Amal Psychiatric Hospital

Sponsor details

Alkozam Aria
Riyadh
00996
Saudi Arabia

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26376830

Publication citations

Additional files

Editorial Notes

22/03/2016: Publication reference added.