Trial Outcomes & Findings for MedActive: A Smartphone Intervention to Improve Adherence to Antipsychotic Medications (NCT NCT01953237)

Results Overview

A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

3 month period

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Control Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.	MedActive Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
Overall Study STARTED	10	21
Overall Study COMPLETED	10	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MedActive: A Smartphone Intervention to Improve Adherence to Antipsychotic Medications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=10 Participants Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.	MedActive n=21 Participants Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.	Total n=31 Participants Total of all reporting groups
Age, Continuous	45.7 years STANDARD_DEVIATION 12.9 • n=5 Participants	49.5 years STANDARD_DEVIATION 10.2 • n=7 Participants	48.3 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiple races	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 month period

A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed

Outcome measures

Outcome measures
Measure	Control n=10 Participants Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.	MedActive n=21 Participants Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
Adherence to Antipsychotic Medications	92.6 percentage of days adherent Standard Deviation 10.6	93.4 percentage of days adherent Standard Deviation 10.3

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MedActive

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

Julie Kreyenbuhl

University of Maryland, Baltimore

Phone: 410-637-1864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place