Trial Outcomes & Findings for Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment (NCT NCT01909973)
NCT ID: NCT01909973
Last Updated: 2019-10-08
Results Overview
Frequency of medication usage from baseline to end of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline, Week 4, Week 8, Week 12
Results posted on
2019-10-08
Participant Flow
Participant milestones
| Measure |
MedLink System
For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable 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.
|
Treatment As Usual
Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
MedLink System
For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable 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.
|
Treatment As Usual
Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment
Baseline characteristics by cohort
| Measure |
MedLink System
n=8 Participants
For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable 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.
|
Treatment As Usual
n=7 Participants
Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 17.04 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 14.02 • n=7 Participants
|
46 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Frequency of medication usage from baseline to end of treatment
Outcome measures
| Measure |
MedLink System
n=8 Participants
For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable 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.
|
Treatment As Usual
n=7 Participants
Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
|
|---|---|---|
|
Adherence to Antidepressant Medication
Week 12 · 2aii. Stopped meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 2aii. Stopped meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02c. Have you reduced med dosage? - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02d. Have you increased med dosage? - No
|
7 Participants
|
6 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02di. Increased meds due to: Side effects - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02di.Increased meds due to: Symptoms decrease -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02bi. Skipped meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02bi. Skipped meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02bi. Skipped meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02c. Have you reduced med dosage? - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02c. Have you reduced med dosage? - No
|
7 Participants
|
7 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02di. Increased meds due to: Side effects - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02di.Increased meds due to: Symptoms increase -Yes
|
1 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 01. Missed med in last 2 wks? - missed once/twice
|
0 Participants
|
3 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 01. Missed med in last 2 wks? - No, took every day
|
4 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02di. Increased meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 8 · 02di.Increased meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 01. Missed med in last 2 wks? - No, took every day
|
3 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02a. Stopped med during last 2 wks? - Yes
|
0 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02ai. Stopped meds 14 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 01. Missed med in last 2 wks? - missed all 14 days
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 01. Missed med in last 2 wks? - missed 6 to 8 days
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 01. Missed med in last 2 wks? - missed 3 to 5 days
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 01. Missed med in last 2 wks? - missed once/twice
|
2 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 01. Missed med in last 2 wks? - No, took every day
|
6 Participants
|
4 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02a. Stopped med during last 2 wks? - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02a. Stopped med during last 2 wks? - No
|
8 Participants
|
7 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 2aii. Stopped meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 2aii. Stopped meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 2aii. Stopped meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 2aii. Stopped meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 2aii. Stopped meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02b. Skipped med in last 2 wks? - Yes
|
1 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02b. Skipped med in last 2 wks? - No
|
7 Participants
|
7 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02bi. Skipped meds due to: Side effects - Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02bi. Skipped meds due to: Symptoms increase -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02bi. Skipped meds due to: Symptoms decrease -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02bi. Skipped meds due to: Ran out of meds -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02bi. Skipped meds due to: Forgot to take -Yes
|
1 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02bi. Skipped meds due to: Other reason -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02c. Have you reduced med dosage? - No
|
8 Participants
|
7 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02ci. Reduced meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02ci. Reduced meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02ci. Reduced meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02ci. Reduced meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02ci. Reduced meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02ci. Reduced meds due to: Other reason -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02d. Have you increased med dosage? - Yes
|
1 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02di.Increased meds due to: Symptoms increase -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02di.Increased meds due to: Symptoms decrease -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02di.Increased meds due to: Ran out of meds -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02di.Increased meds due to: Forgot to take -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02di.Increased meds due to: Other reason -Yes
|
1 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Baseline · 02ai. Stopped meds 3 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02ai. Stopped meds 14 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Baseline · 02ai. Stopped meds 2 ± 0 days days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 4 · 01. Missed med in last 2 wks? - missed all 14 days
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 01. Missed med in last 2 wks? - missed 6 to 8 days
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 01. Missed med in last 2 wks? - missed 3 to 5 days
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 01. Missed med in last 2 wks? - missed once/twice
|
1 Participants
|
4 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 01. Missed med in last 2 wks? - No, took every day
|
6 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02a. Stopped med during last 2 wks? - Yes
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02a. Stopped med during last 2 wks? - No
|
7 Participants
|
6 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 2aii. Stopped meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 2aii. Stopped meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 2aii. Stopped meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02b. Skipped med in last 2 wks? - Yes
|
1 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 2aii. Stopped meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 2aii. Stopped meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02b. Skipped med in last 2 wks? - Yes
|
0 Participants
|
4 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02b. Skipped med in last 2 wks? - No
|
7 Participants
|
3 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02bi. Skipped meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02bi. Skipped meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
3 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02bi. Skipped meds due to: Other reason -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02ci. Reduced meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 4 · 02ci. Reduced meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 4 · 02ci. Reduced meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 4 · 02ci. Reduced meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 4 · 02ci. Reduced meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 4 · 02ci. Reduced meds due to: Other reason -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 4 · 02d. Have you increased med dosage? - Yes
|
1 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02d. Have you increased med dosage? - No
|
6 Participants
|
5 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02di.Increased meds due to: Ran out of meds -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02di.Increased meds due to: Forgot to take -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02di.Increased meds due to: Other reason -Yes
|
0 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02b. Skipped med in last 2 wks? - No
|
4 Participants
|
5 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02ai. Stopped meds 3 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02ai. Stopped meds 14 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 4 · 02ai. Stopped meds 2 ± 0 days days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 01. Missed med in last 2 wks? - missed all 14 days
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 01. Missed med in last 2 wks? - missed 6 to 8 days
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 01. Missed med in last 2 wks? - missed 3 to 5 days
|
1 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02a. Stopped med during last 2 wks? - Yes
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02a. Stopped med during last 2 wks? - No
|
5 Participants
|
6 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 2aii. Stopped meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 2aii. Stopped meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 2aii. Stopped meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 2aii. Stopped meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 2aii. Stopped meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02b. Skipped med in last 2 wks? - Yes
|
1 Participants
|
3 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02b. Skipped med in last 2 wks? - No
|
4 Participants
|
4 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02bi. Skipped meds due to: Side effects - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02bi. Skipped meds due to: Symptoms increase -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02bi. Skipped meds due to: Symptoms decrease -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02bi. Skipped meds due to: Ran out of meds -Yes
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02bi. Skipped meds due to: Forgot to take -Yes
|
0 Participants
|
2 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02bi. Skipped meds due to: Other reason -Yes
|
1 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02c. Have you reduced med dosage? - Yes
|
1 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02c. Have you reduced med dosage? - No
|
4 Participants
|
6 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ci. Reduced meds due to: Side effects - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ci. Reduced meds due to: Symptoms increase -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ci. Reduced meds due to: Symptoms decrease -Yes
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ci. Reduced meds due to: Ran out of meds -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ci. Reduced meds due to: Forgot to take -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ci. Reduced meds due to: Other reason -Yes
|
1 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02d. Have you increased med dosage? - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02d. Have you increased med dosage? - No
|
5 Participants
|
7 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02di.Increased meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 8 · 02di.Increased meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 8 · 02di.Increased meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 8 · 02di.Increased meds due to: Other reason -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 8 · 02ai. Stopped meds 3 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ai. Stopped meds 14 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 8 · 02ai. Stopped meds 2 ± 0 days days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 01. Missed med in last 2 wks? - missed all 14 days
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 01. Missed med in last 2 wks? - missed 6 to 8 days
|
1 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 01. Missed med in last 2 wks? - missed 3 to 5 days
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 01. Missed med in last 2 wks? - missed once/twice
|
1 Participants
|
3 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02a. Stopped med during last 2 wks? - No
|
5 Participants
|
5 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 2aii. Stopped meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 2aii. Stopped meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 2aii. Stopped meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02bi. Skipped meds due to: Side effects - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02bi. Skipped meds due to: Symptoms increase -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02bi. Skipped meds due to: Symptoms decrease -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02bi. Skipped meds due to: Ran out of meds -Yes
|
0 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02bi. Skipped meds due to: Forgot to take -Yes
|
1 Participants
|
1 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02bi. Skipped meds due to: Other reason -Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02c. Have you reduced med dosage? - Yes
|
1 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02c. Have you reduced med dosage? - No
|
4 Participants
|
7 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02ci. Reduced meds due to: Side effects - Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02ci. Reduced meds due to: Symptoms increase -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02ci. Reduced meds due to: Symptoms decrease -Yes
|
1 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02ci. Reduced meds due to: Ran out of meds -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02ci. Reduced meds due to: Forgot to take -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02ci. Reduced meds due to: Other reason -Yes
|
0 Participants
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02d. Have you increased med dosage? - Yes
|
0 Participants
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02d. Have you increased med dosage? - No
|
5 Participants
|
7 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02di. Increased meds due to: Side effects - Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02di.Increased meds due to: Symptoms increase -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02di.Increased meds due to: Symptoms decrease -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02di.Increased meds due to: Ran out of meds -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02di.Increased meds due to: Forgot to take -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02di.Increased meds due to: Other reason -Yes
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
|
Adherence to Antidepressant Medication
Week 12 · 02ai. Stopped meds 3 days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
0 Participants
|
|
Adherence to Antidepressant Medication
Week 12 · 02ai. Stopped meds 2 ± 0 days days ago
|
NA Participants
This follow-up item was not administered for this group and timepoint.
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12The 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 System
n=8 Participants
For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable 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.
|
Treatment As Usual
n=7 Participants
Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
15.25 units on a scale
Standard Deviation 6.07
|
11.43 units on a scale
Standard Deviation 2.15
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 4
|
10.57 units on a scale
Standard Deviation 8.64
|
5.57 units on a scale
Standard Deviation 2.94
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 8
|
5.80 units on a scale
Standard Deviation 4.55
|
3.43 units on a scale
Standard Deviation 2.51
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 12
|
5.20 units on a scale
Standard Deviation 2.39
|
2.00 units on a scale
Standard Deviation 2.24
|
Adverse Events
MedLink System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment As Usual
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