NCT00917410

Brief Summary

The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management. Objective: The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

6 months

First QC Date

June 5, 2009

Last Update Submit

June 9, 2009

Conditions

Outcome Measures

Primary Outcomes (4)

  • Asthma control test

  • EQ-5D

    0, 45, 90 days

  • Use of health services

    0, 45, 90 days

  • Use of preventive medicine

    0, 45, 90 days

Study Arms (1)

SMS intervention

EXPERIMENTAL
Behavioral: SMS support

Interventions

SMS supportBEHAVIORAL

The intervention consisted of sequences of SMS messages sent to the intervention group, each containing 2 or 3 monitoring questions and one reminder to take the preventive medication. The SMS sequence was as follows. 1. Remember to take your preventive asthma medication (sent at 8.00 am). 2. Were you awakened during the night due to your asthma? Answer YES or NO. 3. How many times have you taken your asthma attack medication during the last 24 hours? Answer a number. 4. What was your peak flow this morning? Answer a number (optional, depending on the participant's use of a spirometer prior to the study).

SMS intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • asthmatics

You may not qualify if:

  • below 18 and above 45
  • COPD patients
  • no mobile phone
  • not using the prescribed asthma inhalation medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Claus Møldrup, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 10, 2009

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 10, 2009

Record last verified: 2009-06

Locations