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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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27 February 2017 |
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Main ID: |
ISRCTN58068252 |
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Date of registration:
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07/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of online platform Red Sinapsis monitoring in the quality of life of people with fibromyalgia
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Scientific title:
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Effectiveness of online platform Red Sinapsis monitoring in the quality of life of people with fibromyalgia: A randomized controlled 1-year follow-up study |
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Date of first enrolment:
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03/07/2013 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN58068252 |
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Study type:
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Interventional |
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Study design:
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Single-centre randomised controlled trial (Quality of life)
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Eva
García-Perea |
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Address:
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Universidad Autónoma de Madrid
Facultad de Medicina
Arzobispo Morcillo, 2.
28029
Madrid
Spain |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 years and over
2. Diagnosed with Fibromyalgia following the American College of Rheumatology criteria
3. Have access to a computer
Exclusion criteria: 1. Those who not have a computer or means to be followed up online
2. People with severe cognitive or mental disorders
3. Not providing informed consent to participate.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia
Nervous System Diseases
Fibromyalgia
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Intervention(s)
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Participants are randomised to one of two groups.
Intervention group: Participants are telephoned and they are called in to the clinic to register them in the Red Sinapsis platform and assign them the access codes, giving them a few instructions for using the system. It is explained that the messages will be taken care of during consultation hours from Monday to Friday from 10 a.m. to 10 p.m., although the patient can use the messenger at the time he wants. To ensure that the patient has no doubts about the management of the platform, a message is sent to those patients who have not been connected to the platform within 15 days of being logged into the system. In these messages they are asked about their doubts or possible connection problems. If no response is received, then participants are contacted by telephone. Through the messages to the patient, information is provided based on the available scientific evidence, correctly documented related to their illness (FM) and the medication they habitually consume, providing data sheets containing the indications, side effects, contraindications and interactions from the same.
Control group: Participants are telephoned and told that they are in the control group and will not be using the Red Sinapsis platform. Participants then continue to receive usual care for the duration of the study.
At baseline, 6 and 12 months, participants in both groups complete a range of questionnaires.
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Primary Outcome(s)
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1. Perception of health status is assessed using the FIQ and SF-36 questionnaires at baseline, 6 and 12 months
2. Emotional state (anxiety and depression) is assessed using the FIQ and SF-36 questionnaires at baseline, 6 and 12 months
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Secondary Outcome(s)
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Degree of satisfaction with the platform usage is assessed using a survey designed for the purpose of this study at 12 months (intervention group only).
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Secondary ID(s)
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UAM-CEI-46-894
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Source(s) of Monetary Support
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Universidad Autónoma de Madrid
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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