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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04761757
Other study ID # ADAM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date October 30, 2020

Study information

Verified date February 2021
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Antidepressant Decision Aid for Major Depressive Disorder is feasible and effective in involving patients in the decision-making process when initiating pharmacotherapy.


Description:

To examine the ability of the patient decision aid to enhance shared decision making and preparedness to make decisions pertaining to antidepressant therapy. The research team has systematically developed an Antidepressant Decision Aid for Major depressive disorder patients (ADAM) according to the International Patient Decision Aids Standards (IPDAS) and the Ottawa Decision Support Framework. This is a posttest-only study with nonequivalent groups to evaluate the effect of the antidepressant decision aid on patient and physician perception of shared decision making as well as patient preparedness for making pharmacotherapeutic decisions compared usual care.


Recruitment information / eligibility

Status Completed
Enrollment 752
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with Major Depressive Disorder (MDD) - No psychotic symptoms - Based on psychiatrist's clinical judgement currently in need for antidepressant treatment. - Functional English literacy and language skills (to use the decision aid and fill out the questionnaires) - Provides consent Exclusion Criteria: - Psychosis - Communication barriers (visual impairment, language barrier)

Study Design


Intervention

Other:
Booklet of Scripts of Doctors
The "Booklet of Scripts for Doctors" was used in the control arm. This tool was developed and tested to encourage shared decision-making in prescribing antidepressants within the Malaysian context.
Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)
The "Booklet of Scripts for Doctors" along with the "Antidepressant Decision Aid for Major depressive disorder patients, ADAM", was used in the intervention arm. The decision aid was developed as per the International Patient Decision Aid Standards (IPDAS) criteria to enhance patient understanding of risks and benefits of different antidepressants available within the Malaysian context.

Locations

Country Name City State
Malaysia KPJ Ampang Puteri Specialist Hospital Ampang Kuala Lumpur
Malaysia Hospital Pulau Pinang George Town Pulau Pinang
Malaysia Hospital Raja Permaisuri Bainun Ipoh Perak
Malaysia Hospital Permai Johor Bahru Johor
Malaysia Sultanah Aminah Hospital Johor Bahru Johor
Malaysia Dr Seed Specialist Clinic Kepong Kuala Lumpur
Malaysia Hospital Pusrawi Kuala Lumpur
Malaysia Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist Kuala Lumpur
Malaysia Pusat Perubatan Universiti Kebangsaan Malaysia Kuala Lumpur
Malaysia University of Malaya Medical Centre Kuala Lumpur
Malaysia Hospital Sultanah Nur Zahirah Kuala Terengganu Terengganu
Malaysia Hospital Umum Sarawak Kuching Sarawak
Malaysia Columbia Asia Hospital Nusajaya Johor
Malaysia A. H. Lee Specialist Clinic Petaling Jaya Selangor
Malaysia Hospital Putrajaya Putrajaya
Malaysia Hospital Pengajar Universiti Putra Malaysia Serdang Kuala Lumpur
Malaysia Hospital Sultan Haji Ahmad Shah Temerloh Pahang

Sponsors (2)

Lead Sponsor Collaborator
University of Malaya Ministry of Education, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shared Decision Making_Patient Perspective The patient version of the Shared Decision Making scale (SDM-Q-9) measures the extent to which patients are involved in the decision-making process from the patient's perspective. It consists of nine items rated on a six-point Likert-type scale from"completely disagree=" to"completely agree=". Adding the score of all the items leads to a raw total between 0 and 45. Multiplying the raw score by 20/9 provides a transformed score ranging from 0 to 100, higher scores indicate a greater extent of SDM. Immediately after the clinical encounter
Primary Shared Decision Making_Physician Perspective The physician version of Shared Decision Making scale (SDM-Q-Doc) measures the extent to which patients are involved in the decision-making process from the physician's perspective. It consists of nine items rated on a six-point Likert-type scale from"completely disagree=" to"completely agree=". Adding the score of all the items leads to a raw total between 0 and 45. Multiplying the raw score by 20/9 provided a transformed score ranging from 0 to 100, higher scores indicate a greater extent of SDM. Immediately after the clinical encounter
Primary Preparation for Decision Making_Patient Perspective The patient version of the Preparation for Decision-Making Scale (PDMS) assesses the patient's perception of how the PDA helped them recognize that a decision needs to be made, preparing them to communicate with their practitioner and promote patient involvement in the decision-making process. Higher scores indicate a higher perceived level of preparation for decision making. Immediately after the clinical encounter
Primary Preparation for Decision Making_Physician Perspective The physician version of the Preparation for Decision-Making Scale (PDMS) assesses the physician's perception of how the PDA helped patients recognize that a decision needs to be made, preparing them to communicate with their practitioner and promote patient involvement in the decision-making process. Higher scores indicate a higher perceived level of preparation for decision making. Immediately after the clinical encounter
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