The Antidepressant Advisor Study (ADeSS)
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|ClinicalTrials.gov Identifier: NCT03628027|
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Computerised decision support algorithm||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster-randomised controlled clinical trial. GPs are randomised in blocks of N = 2 to a treatment arm. All patients under the care of a GP receive the treatment to which the GP was randomised.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||GPs will need to be made aware of their treatment arm in order to implement the correct treatment. However, this should not be disclosed to patients, either by the GP or Trial Co-ordinator who will also be blinded.|
|Official Title:||The Antidepressant Advisor: A Decision Support System for UK Primary care-a Feasibility Study|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Treatment Algorithm
The treatment algorithm arm will be the experimental arm in which GPs use the computerised decision support tool to guide their prescribing of antidepressants.
Device: Computerised decision support algorithm
The algorithm is integrated into the EMIS computer system used by GPs. The algorithm advises on which antidepressants should be prescribed based on a patient's treatment history.
No Intervention: Treatment-as-usual
The treatment-as-usual arm will comprise GPs prescribing antidepressants and providing care as they typically would.
- Self-Rated Quick Inventory of Depressive Symptomatology (QIDS-SR16) [ Time Frame: 16 weeks ]Change from baseline depressive symptoms (not primary outcome for this feasibility study, only for full trial, primary feasibility outcomes are listed from 6 onwards). Total scale range: 0 - 48. Higher score indicates more change in depressive symptoms.
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 16 weeks ]Change from baseline depressive symptoms. Total scale range: 0 - 60. Higher score indicates more change in depressive symptoms.
- Clinical Global Impression [ Time Frame: 16 weeks ]Change from baseline severity Total scale range: 1 - 7. Lower score indicates more improvement in symptoms.
- Generalised Anxiety Disorder (GAD-7) [ Time Frame: 16 weeks ]Change from baseline anxiety symptoms used in the NHS. Total scale range: 0 - 21. Higher score indicates more change in anxiety symptoms.
- Body Mass Index (BMI) [ Time Frame: 16 weeks ]Change from baseline healthy weight. Total range: 12 - 42. Higher score indicates more change in BMI.
- Recruitment Rate [ Time Frame: Through study completion, an average of 16 months ]Rate at which patients are recruited to the study
- Lost to Follow-up Rate [ Time Frame: Through study completion, an average of 16 months ]Rate at which patients are lost to follow-up
- Adverse Event Rate [ Time Frame: Through study completion, an average of 16 months ]Grade and rate at which adverse events occur
- Helpfulness, ease of use and workload of intervention using King's GP Satisfaction Measure [ Time Frame: Through study completion, an average of 16 months ]Average GP satisfaction. Includes recommendation for future clinical use, and opinion on usefulness to patient care. Subscale ranges-Q1: 0 - 11, Q2: 0 - 6 (higher score indicates more improved care), Q3: 0 - 6 (higher score indicates higher workload), Q4: 0 - 6 (higher score indicates higher helpfulness), Q5: 0 - 6 (higher score indicates higher workload), Q6: 0 - 6 (higher score indicates easier to use), Q7: 0 - 6 (higher score indicates more improvement in care), Q8: 0 - 6 (higher score indicates better than other tools), Q9: 0 - 6 (higher score indicates less likelihood to ignore tool), Q10: 0 - 6 (higher score indicates more strongly recommend)
- GP Adherence to Algorithm [ Time Frame: Week 16 ]Assessed for each patient by trial clinician, from 0 (none of the recommended steps implemented) to 3 (fully implemented)
- Service Use (EMIS) [ Time Frame: Week 16 ]Information taken from EMIS, including psychiatric referrals, referrals to study psychiatrist, time to psychiatric referral
- Adult Service Use Schedule (AD-SUS) [ Time Frame: Week 16 ]Assessed on routine validated KCL questionnaire. Subscale ranges: Q1: 0 (no) 1 (yes), Q2: continuous number, Q3: 0 (no), 1 ( yes), Q4: continuous number, Q5: 0 (no), 1 (yes), Q6: text answer, Q7: continuous number
- Euroqol Quality of Life Measure (EQ-5D-3L) [ Time Frame: Week 16 ]Change from baseline quality of life. Assessment of cost-effectiveness of intervention. Visual analogue question range: 0 - 100. Higher score indicates better perceived health.
- Average % Patient Adherence (EMIS) [ Time Frame: Week 16 ]Information taking from EMIS including prescribing records
- Social and Occupational Functioning Assessment Scale (SOFAS; DSM-V) [ Time Frame: Week 16 ]Change from baseline psychological functioning
- Maudsley Visual Analogue Mood Scale [ Time Frame: Week 16 ]Change from baseline mood. Total scale range: 0 - 300. Higher scores indicate more improvement in mood.
- Patient Adherence [ Time Frame: Week 16 ]Information taken from EMIS including % of attended GP visits out of total scheduled number
- Frequency, Intensity and Burden of Side Effects Rating (FIBSER) [ Time Frame: Weekly for 16 weeks ]Average score for medication side effects. Each subscale range: 0 - 6. Higher scores indicate more burdensome side effects.
- Average % Patient Adherence (Mobile App) [ Time Frame: Weekly for 16 weeks ]Adherence to prescribed antidepressants
- Average Maudsley Modified Patient Health Questionnaire (PHQ-9) [ Time Frame: Weekly for 16 weeks ]Average depression score over last 2 weeks. Total scale range: 0 - 21. Higher scores indicate more depressive symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628027
|Contact: Phillippa Harrison, BScemail@example.com|
|Contact: Roland Zahn||020 7848 firstname.lastname@example.org|
|King's College London, IoPPN||Recruiting|
|London, United Kingdom, SE5 8AF|
|Contact: Phillippa Harrison 07527952622|
|Contact: Roland Zahn email@example.com|
|Principal Investigator: Roland Zahn|
|Sub-Investigator: Allan H Young|
|Sub-Investigator: Mark Ashworth|
|Sub-Investigator: Kimberley Goldsmith|
|Sub-Investigator: Barbara Barrett|
|Principal Investigator:||Roland Zahn||Senior Clinical Lecturer, Honorary Consultant Psychiatrist|
|Study Director:||Phillippa Harrison||Post-doctoral Research Associate|