NCT02189616

Brief Summary

Asthma is the disease being studied. The main objective of this study is to assess the clinical efficacy of mobile phone short message service (SMS) reminder and consultation on the self-management and outcomes of poorly controlled asthma which is first diagnosed in a time period of 3 months. The secondary objective is to explore the cost-benefit and cost-effectiveness of the proposed intervention. Aims: The main aim of this study is to assist asthma patients to practice asthma self-management at home by sending reminders and responding to patients' consultations with mobile phone short message service (SMS), which will eventually help them to control their asthma, and prevent asthma exacerbation. Thus, the ultimate goal of this proposed study is to improve patient health outcome via enhancing patient-physician interaction through mobile phone short message service (SMS) that is low-cost and could be followed easily by the patients and their physicians. The hypothesis is that asthma patients who receive weekly text message reminders to educate them and reinforce adherence will have better asthma outcome, such as asthma control, while the intervention integrating patient consultation and reminders by SMS improve asthma outcome even more. The investigators further hypothesize that these subjects under intervention will have an improvement in secondary measures including quality of life and patient satisfaction. The investigators also anticipate that such an approach in asthma management will be cost-effective.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

March 24, 2014

Last Update Submit

August 18, 2014

Conditions

Keywords

asthma managementSMS reminderSMS consultation

Outcome Measures

Primary Outcomes (2)

  • change in asthma control measured by Asthma Control Test(ACT)

    change in asthma control measured by Asthma Control Test(ACT) between baseline and 3 months after randomization.

    3 months

  • score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)

    score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) at baseline and 3 months

    3 months

Secondary Outcomes (2)

  • Mini-asthma quality of life questionnaire (mini-AQLQ)

    3 months

  • asthma control

    3 months

Other Outcomes (1)

  • cost effectiveness

    3 months

Study Arms (3)

regular care group

OTHER

receive regular care which contains filling a paper asthma diary daily.

Other: regular care

SMS reminder group

EXPERIMENTAL

receive weekly mobile phone short message reminders for 3 months

Behavioral: SMS reminderOther: regular care

SMS reminder and SMS consultation group

EXPERIMENTAL

receive weekly mobile phone short message reminders and can consult asthma nurse by mobile phone short message when needed for 3 months

Behavioral: SMS reminderOther: SMS consultationOther: regular care

Interventions

SMS reminderBEHAVIORAL

send weekly mobile phone short message reminders to the intervention group

SMS reminder and SMS consultation groupSMS reminder group

told patients to consult qualified asthma nurses by SMS when they need

SMS reminder and SMS consultation group

patients are asked to fill in their paper asthma diary daily for 3 months

SMS reminder and SMS consultation groupSMS reminder groupregular care group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosed uncontrolled or partly-controlled asthma by Global Initiative for Asthma(GINA) standard.
  • At least 6 months asthma history.
  • Ownership of a mobile phone and currently using the text messaging service.
  • Age between 18 and 65 years old.
  • Willingness to participate in this study.
  • Willing to sign the written informed consent to take part in the study.

You may not qualify if:

  • Inability to provide written informed consent or to fill in the paper asthma diary.
  • A history of smoking cigarettes for greater than ten pack years.
  • Other current or a history of severe comorbidity.
  • Being in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • liqiang song, doctor

    first affiliated hospital, the fourth military medical university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Wang, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director of department of respirotary and critical care medine

Study Record Dates

First Submitted

March 24, 2014

First Posted

July 14, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations