Trial Outcomes & Findings for Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment (MedLink) (NCT NCT02583230)
NCT ID: NCT02583230
Last Updated: 2018-10-29
Results Overview
Number of days medication was taken when a dose was expected. Measured through % of days adherent on Wisepill pillbox as well as 2. Self-reported adherence: Patient Adherence Questionnaire (PAQ).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-10-29
Participant Flow
Participant milestones
| Measure |
MedLink
For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.
MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status.
|
|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment (MedLink)
Baseline characteristics by cohort
| Measure |
MedLink
n=11 Participants
For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.
MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status.
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|---|---|
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Age, Continuous
|
45.1 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Marital Status
Single
|
7 Participants
n=5 Participants
|
|
Marital Status
Living with significant other
|
1 Participants
n=5 Participants
|
|
Marital Status
Married/Domestic partner
|
3 Participants
n=5 Participants
|
|
Education
Some high school
|
1 Participants
n=5 Participants
|
|
Education
Completed high school
|
1 Participants
n=5 Participants
|
|
Education
4-year college (BA, BS)
|
5 Participants
n=5 Participants
|
|
Education
Master's degree
|
4 Participants
n=5 Participants
|
|
Employment status
Employed
|
7 Participants
n=5 Participants
|
|
Employment status
Unemployed
|
1 Participants
n=5 Participants
|
|
Employment status
Retired
|
2 Participants
n=5 Participants
|
|
Employment status
Student
|
1 Participants
n=5 Participants
|
|
Mobile device
Personal device
|
4 Participants
n=5 Participants
|
|
Mobile device
Study provided device
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksNumber of days medication was taken when a dose was expected. Measured through % of days adherent on Wisepill pillbox as well as 2. Self-reported adherence: Patient Adherence Questionnaire (PAQ).
Outcome measures
| Measure |
MedLink
n=11 Participants
For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.
MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status.
|
|---|---|
|
Adherence to Antidepressant Medication
|
82.0 % of days adherent
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.
Outcome measures
| Measure |
MedLink
n=11 Participants
For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.
MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status.
|
|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
12.0 units on a scale
Standard Deviation 4.0
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|
Patient Health Questionnaire-9 (PHQ-9)
Week 4
|
5.3 units on a scale
Standard Deviation 4.6
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 8
|
3.5 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 8This measure assesses depressive symptom severity. The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD (major depressive disorder) criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003). Sixteen items are used to rate the nine criterion symptom domains of a major depressive episode. Each item is rated 0-3. For symptom domains that require more than one item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. Higher values represent a worse outcome. Specifically, scores of 0-5 indicate no depression; 6-10 is mild; 11-15 is moderate; 16-20 is severe; and 21-27 is very severe.
Outcome measures
| Measure |
MedLink
n=11 Participants
For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enabled pill bottle in order to provide and receive feedback regarding medication adherence.
MedLink System: Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status.
|
|---|---|
|
Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C)
Baseline
|
11.6 units on a scale
Standard Deviation 3.7
|
|
Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C)
Week 4
|
7.6 units on a scale
Standard Deviation 5.6
|
|
Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C)
Week 8
|
4.6 units on a scale
Standard Deviation 4.0
|
Adverse Events
MedLink
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place