Trial registration number
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ISRCTN38746119 |
Full text link
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.isrctn.com/ISRCTN38746119
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First author
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Hiyam Al-Jabr
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Contact
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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h.al-jabr@uos.ac.uk
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Registration date
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-10-08
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Recruitment status
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Long covid
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Inclusion criteria
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Adult (18+ years with no upper age limit). 2. COVID-19 infection confirmed through PCR testing or clinical diagnosis from GP. 3. Experiencing post-COVID-19 syndrome (as defined by NICE 2020) 12 weeks or more following onset of symptoms / confirmed through testing. 4. Able to participate in telephone interview in English language (or with accommodated adjustments). 5. Able to consent to participate in study.
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Exclusion criteria
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Children and young adults (17 years and under). 2. Unable to consent to participate in study, despite reasonable adjustments being implemented. 3. Unable to participate in telephone interview in English language, where the research team have been unable to make adjustments to enable their participation.
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Number of arms
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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University of Suffolk
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Inclusion age min
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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United Kingdom
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Type of patients
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients recovered from covid
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Severity scale
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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primary outcome
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Feasibility and acceptability measured by: 1. Recruitment and retention rates measured by identifying the number of participants taking part in the study (from start to end) and number of participants who withdraw from the study at any point. 2. Acceptability and satisfaction of the LC-OHP measured by: 2.1. Conducting a telephone interview with a sample of participants in the intervention group at the end of the trial 2.2. Asking participants in the intervention group to complete the Course Experience Questionnaire (CEQ) at the end of the trial Participants who decide to withdraw from the trial will also be invited to a short interview to assess their views of the LC-OHP and any changes that they may wish to suggest. Interviews will be held as soon after they withdraw 3. Acceptability of secondary outcome measures measured using telephone interview with a sample of participants in the intervention group at the end of the trial
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Notes
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1982, "treatment_name": "Long covid optimal health program", "treatment_type": "Care protocol", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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