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Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SMS reminder
SMS consultation
regular care
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma management, SMS reminder, SMS consultation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

regular care group

SMS reminder group

SMS reminder and SMS consultation group

Arm Description

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

receive weekly mobile phone short message reminders for 3 months

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Mini-asthma quality of life questionnaire (mini-AQLQ)
mini-AQLQ scores at baseline and 3 months after the randomization
asthma control
change of asthma control level indicated by symptom score, PEF and asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing) from baseline to the end of intervention(3 months)

Full Information

First Posted
March 24, 2014
Last Updated
August 18, 2014
Sponsor
Xijing Hospital
Collaborators
Baoji Central Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02189616
Brief Title
Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control
Official Title
Evaluate the Clinical Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on the Self-management and Outcomes of Poorly-controlled Asthma: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
Collaborators
Baoji Central Hospital, Hanzhong Central Hospital, Yan'an University Affiliated Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
After examined for their eligibility and recruited into this study at outpatient service, all participants have their case records which contain their baseline data and receive the same standard asthma education(including basic knowledge about asthma, how to use their medicine, what to do when an asthma attack happens and when to come back for their disease review and so on). Each patient is given a paper asthma diary and a peak expiratory flow(PEF) measurer for free. In addition, they are told what intervention they will receive and revised face-to-face one month after the beginning of intervention. After the 3-month study period, when they return to the hospitals, they will return the asthma diaries, be asked to fill in the questionnaires and take pulmonary function tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma management, SMS reminder, SMS consultation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
regular care group
Arm Type
Other
Arm Description
receive regular care which contains filling a paper asthma diary daily.
Arm Title
SMS reminder group
Arm Type
Experimental
Arm Description
receive weekly mobile phone short message reminders for 3 months
Arm Title
SMS reminder and SMS consultation group
Arm Type
Experimental
Arm Description
receive weekly mobile phone short message reminders and can consult asthma nurse by mobile phone short message when needed for 3 months
Intervention Type
Behavioral
Intervention Name(s)
SMS reminder
Intervention Description
send weekly mobile phone short message reminders to the intervention group
Intervention Type
Other
Intervention Name(s)
SMS consultation
Intervention Description
told patients to consult qualified asthma nurses by SMS when they need
Intervention Type
Other
Intervention Name(s)
regular care
Intervention Description
patients are asked to fill in their paper asthma diary daily for 3 months
Primary Outcome Measure Information:
Title
change in asthma control measured by Asthma Control Test(ACT)
Description
change in asthma control measured by Asthma Control Test(ACT) between baseline and 3 months after randomization.
Time Frame
3 months
Title
score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ)
Description
score of knowledge, attitude, and self efficacy asthma questionnaire (KASE-AQ) at baseline and 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mini-asthma quality of life questionnaire (mini-AQLQ)
Description
mini-AQLQ scores at baseline and 3 months after the randomization
Time Frame
3 months
Title
asthma control
Description
change of asthma control level indicated by symptom score, PEF and asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing) from baseline to the end of intervention(3 months)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
cost effectiveness
Description
The cost effectiveness of SMS reminder and consultation interventions compared to controls without study interventions.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Wang, master
Phone
18909233806
Email
ddys1211@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
liqiang song, doctor
Organizational Affiliation
first affiliated hospital, the fourth military medical university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhikui li, doctor
Phone
13571855922
Email
lizhikui@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
liqiang song, doctor
Phone
13991160546
Email
songlq@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaofan Hu, Bachelor
First Name & Middle Initial & Last Name & Degree
liqiang song, doctor

12. IPD Sharing Statement

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Efficacy of Mobile Phone Short Message Service (SMS) Reminder and Consultation on Asthma Control

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