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Antidepressant Decision Aid for Major Depressive Disorder Patients (ADAM)

Primary Purpose

Depression, Depressive Symptoms, Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Booklet of Scripts of Doctors
Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Shared decision making, Patient decision aid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital Permai
  • Sultanah Aminah Hospital
  • Columbia Asia Hospital
  • KPJ Ampang Puteri Specialist Hospital
  • Dr Seed Specialist Clinic
  • Hospital Pengajar Universiti Putra Malaysia
  • Hospital Sultan Haji Ahmad Shah
  • Hospital Raja Permaisuri Bainun
  • Hospital Pulau Pinang
  • Hospital Umum Sarawak
  • A. H. Lee Specialist Clinic
  • Hospital Sultanah Nur Zahirah
  • Hospital Pusrawi
  • Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist
  • Pusat Perubatan Universiti Kebangsaan Malaysia
  • University of Malaya Medical Centre
  • Hospital Putrajaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Arm

Intervention Arm

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2021
Last Updated
February 17, 2021
Sponsor
University of Malaya
Collaborators
Ministry of Education, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04761757
Brief Title
Antidepressant Decision Aid for Major Depressive Disorder Patients
Acronym
ADAM
Official Title
Antidepressant Decision Aid for Major Depressive Disorder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
Collaborators
Ministry of Education, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Symptoms, Depressive Disorder, Major, Mood Disorders
Keywords
Shared decision making, Patient decision aid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Title
Intervention Arm
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Booklet of Scripts of Doctors
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shared Decision Making_Patient Perspective
Description
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.
Time Frame
Immediately after the clinical encounter
Title
Shared Decision Making_Physician Perspective
Description
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.
Time Frame
Immediately after the clinical encounter
Title
Preparation for Decision Making_Patient Perspective
Description
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.
Time Frame
Immediately after the clinical encounter
Title
Preparation for Decision Making_Physician Perspective
Description
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.
Time Frame
Immediately after the clinical encounter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aya Ahmed Abousheishaa
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ng Chong Guan
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Permai
City
Johor Bahru
State/Province
Johor
Country
Malaysia
Facility Name
Sultanah Aminah Hospital
City
Johor Bahru
State/Province
Johor
Country
Malaysia
Facility Name
Columbia Asia Hospital
City
Nusajaya
State/Province
Johor
Country
Malaysia
Facility Name
KPJ Ampang Puteri Specialist Hospital
City
Ampang
State/Province
Kuala Lumpur
Country
Malaysia
Facility Name
Dr Seed Specialist Clinic
City
Kepong
State/Province
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Pengajar Universiti Putra Malaysia
City
Serdang
State/Province
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Sultan Haji Ahmad Shah
City
Temerloh
State/Province
Pahang
Country
Malaysia
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
George Town
State/Province
Pulau Pinang
Country
Malaysia
Facility Name
Hospital Umum Sarawak
City
Kuching
State/Province
Sarawak
Country
Malaysia
Facility Name
A. H. Lee Specialist Clinic
City
Petaling Jaya
State/Province
Selangor
Country
Malaysia
Facility Name
Hospital Sultanah Nur Zahirah
City
Kuala Terengganu
State/Province
Terengganu
Country
Malaysia
Facility Name
Hospital Pusrawi
City
Kuala Lumpur
Country
Malaysia
Facility Name
Klinik Pakar Dr Yeoh & Dr Hazli Mental Health Specialist
City
Kuala Lumpur
Country
Malaysia
Facility Name
Pusat Perubatan Universiti Kebangsaan Malaysia
City
Kuala Lumpur
Country
Malaysia
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Putrajaya
City
Putrajaya
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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Antidepressant Decision Aid for Major Depressive Disorder Patients

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