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Patient Adherence to Acupuncture Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645083
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
David Black, University of Southern California

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adherence, Patient Behavioral: Telephone call Behavioral: Text message Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Treatment Adherence in Acupuncture Patients: A Randomized Controlled Trail
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Experimental: Telephone call
Participants receive a telephone call reminder three days after their initial visit
 Behavioral: Telephone call
Participants in the intervention group receive a one-time telephone call reminder to attend follow-up treatment at the acupuncture clinic
Experimental: Text message
Participants receive a text message reminder three days after their initial visit
 Behavioral: Text message
Participants in the intervention group receive a one-time text messaging reminder to attend follow-up treatment at the acupuncture clinic
No Intervention: Control
Participants do not receive any intervention after their initial visit


Outcome Measures
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Primary Outcome Measures :
  1. Attendance to follow-up treatment [ Time Frame: Within 30 days after participants' initial visit ]
    Participants attending acupuncture follow-up treatments


Secondary Outcome Measures :
  1. Total number of follow-up treatments [ Time Frame: Within 30 days after participants' initial visit ]
    The total number of follow-up treatments by participants


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645083


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Study Director: David Black, PhD University of Southern California
More Information
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Responsible Party: David Black, Assistant Professor of Preventive Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT03645083    
Other Study ID Numbers: HS-17-00008
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No