Trial Outcomes & Findings for Boost Study 31380 (mHealth) (NCT NCT05757453)

NCT ID: NCT05757453

Last Updated: 2024-12-18

Results Overview

Interactions Completed (interactions completed, range 0 to unbound)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

At 8 weeks

Results posted on

2024-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental MHealth group MHealth: Mobile application
Overall Study STARTED	43
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Boost Study 31380 (mHealth)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=43 Participants MHealth group MHealth: Mobile application
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Female	14 Participants n=5 Participants
Sex/Gender, Customized Male	29 Participants n=5 Participants
Sex/Gender, Customized Declined to Report	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	4 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 8 weeks

Interactions Completed (interactions completed, range 0 to unbound)

Outcome measures

Outcome measures
Measure	Experimental n=43 Participants mHealth group mHealth: Mobile platform
Interaction Engagement, as Assessed by Interactions Completed	7.3 interactions Interval 1.0 to 28.0

SECONDARY outcome

Timeframe: At 8 weeks

Population: 18 of 21 participants did not complete survey at 8 week outcome measure time frame, resulting from technical error in survey delivery. 3 participants were analyzed.

Subjective scoring of design and function usability, Likert User Experience Scale (score range 1-5, higher better)

Outcome measures

Outcome measures
Measure	Experimental n=3 Participants mHealth group mHealth: Mobile platform
Intervention Usability Rating, as Assessed by Likert User Experience Scale	4.7 units on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: At 8 weeks

Patient-Centered instrument for evaluating progress, TEA Score (scale range 4 to 40, higher better), assessed weekly for 8 weeks with week 8 reported

Outcome measures

Outcome measures
Measure	Experimental n=21 Participants mHealth group mHealth: Mobile platform
Treatment Progress Measure, as Assessed by TEA Score	19 score on a scale Interval 15.0 to 36.0

Adverse Events

Experimental

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

Principal Investigator for Study 31380

NXTech

Phone: 7814721140

Email: external+[email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place