Clinical trial NCT03645083: Patient Adherence to Acupuncture Treatment
Official title: Improving Treatment Adherence in Acupuncture Patients: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Patient
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Adherence to treatment recommendation remains low among acupuncture patients. This study aims to examine whether implementing a post-initial visit follow-up strategy can improve adherence rate. Adult patients visiting the acupuncture clinic for a new treatment will be randomized to receive a telephone call or a text-message three days after their initial visit against a control group. We will enroll up to 160 participants between February and December 2017, to ensure we can reach 120 subjects in the analysis who completed the baseline survey. Participants recruitment will take place at the Emperor's College of Traditional Oriental Medicine Acupuncture Clinic. Assessments will be conducted via surveys at four times points, Day 0 (date of enrollment), Day 3, Day 10 and Day 30. Additional data will also be collected via chart review. Primary outcome will be assessing whether participants return for any follow-up visit within 30 days after the initial treatment. Secondary outcomes will examine if factors such as expectations, intention, satisfaction, and potential barriers would predict the primary outcome.

Detailed description: This randomized controlled trial will deliver two interventions: (1) telephone call reminder and (2) text messaging reminder.

Participants who meet study eligibility criteria based on intake assessment will be recruited and complete baseline assessment immediately after they receive acupuncture treatment. There will be 40 participants in each of the two intervention groups and the no intervention control group.

Participants will be adults who visit the Emperor's College Acupuncture Clinic for a new treatment consultation on the date of the enrollment.

The telephone call and text messaging intervention is a one-time reminder system delivered to the participants based on the study random assignment, three days after the initial visit. A research assistant will be contacting the participants based on the assigned interventions.

There are three data collection points, 1) baseline (during initial visit), 2) 10 days after the initial visit, and 3) 30 days after the initial visit. Data will be collected via a tablet (baseline) and online survey (Day 10 and Day 30) through a secure online survey platform. Baseline assessment will occur prior to randomization, and post-intervention assessments will occur at 10 to 30 days after the initial visit.

Number of follow-up treatments for the same health concern will be collected for all enrolled participants from the participants' clinical record.

Eligibility criteria: Inclusion Criteria:

* Outside patients seeking acupuncture treatment at Emperor's College Clinic
* Age 18 and above
* English-speaking
* Starting a new treatment at the day of recruitment
* Own a mobile device
* Mobile device has text-messaging capability
* Visiting the Master's Clinic at Emperor's College

Exclusion Criteria:

* Emperor's College's students or staffs seeking acupuncture treatment
* Patients visiting the faculty observation theater, ear acupuncture clinic and private clinic
* Patients returning for a follow-up acupuncture visit at the day of recruitment

Primary outcomes:
measure: Attendance to follow-up treatment
timeFrame: Within 30 days after participants' initial visit
Secondary outcomes:
measure: Total number of follow-up treatments
timeFrame: Within 30 days after participants' initial visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: David Black, PhD
role: STUDY_DIRECTOR
References: