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Can a self-management program help people manage fatigue after critical illness? A small, early study to check if a larger research study is possible

What is the feasibility and acceptability of conducting a randomised controlled trial evaluating a healthcare professional-supported, self-management intervention for people suffering from fatigue after critical illness?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13813593
Enrollment
70
Registered
2025-04-01
Start date
2025-04-15
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue after critical illness Signs and Symptoms

Interventions

Half of the participants will be randomly assigned to the intervention group where they will receive access to the fatigue self-management intervention alongside receiving the usual care offered to pa

Sponsors

Oxford Brookes University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Patient Participant Inclusion Criteria: 1. Adults >=18 years 2. Have been an inpatient in the ICU for a minimum of 72 hours 3. Have required Level 3 care (Failure of two or more organs and/ or requiring advanced respiratory care) (Intensive Care Society, 2021) during their ICU stay 4. Self-reporting symptoms of fatigue at point of discharge (+/- 7 days) from hospital (< 34/ 52 on FACIT-F additional concerns subscale) 5. Ready for discharge (+/- 7 days) from hospital HCP Participant Eligibility Criteria: 1. Healthcare professional registered with a professional body (Nursing and Midwifery Council, General Medical Council, Health, and Care Professionals Council) 2. Directly involved with the intervention delivery for this study

Exclusion criteria

Exclusion criteria: Patient Participant Exclusion Criteria: 1. Expected to survive for < 30 days according to their clinical team 2. A neurological diagnosis occurring as a cause or result of the patient ICU admission (e.g., stroke, traumatic brain injury) or any neurodegenerative condition (E.g. multiple sclerosis, amyotrophic lateral sclerosis) as these specialist groups have different clinical and biological characteristics

Design outcomes

Primary

MeasureTime frame
1. Recruitment and randomisation rate is measured as a proportion of participants recruited and randomised compared to those assessed as eligible, overall and by centre at baseline 2. Retention rate is measured as a proportion of participants who complete the study to its conclusion at 3 and 6 months after randomisation 3. Semi-structured interview of patients’ experiences utilising a topic guide based on the theoretical constructs of acceptability at 6 months after randomisation

Secondary

MeasureTime frame
1. Level of coping is measured using Carver’s Brief Coping Orientation to Problems Experienced (COPE) inventory at baseline, 3 and 6 months after randomisation 2. Health-related quality of life is measured using EuroQoL-5 Dimensions (EQ-5D) at baseline, 3 and 6 months after randomisation 3. Level of fatigue is measured using Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) (Full 40-item scale) and Prototype F-ACT Scale (adapted version of Inflammatory Bowel Disease-Fatigue Scale) at baseline, 3 and 6 months after randomisation 4. The impact of fatigue on a person's ability to function is measured using the Work and Social Adjustment Scale (WSAS) at baseline, 3 and 6 months after randomisation 5. A person's cognitive and behavioural response to fatigue is measured using the Cognitive and Behavioural Responses to Symptoms Questionnaire (CBRQ)(Short version) at baseline, 3 and 6 months after randomisation 6. The acceptability of the intervention and trial procedures will be measured using the Theoretical Framework for Acceptability Questionnaire (TFAQ) at 6-months after randomisation 7. The usability of the intervention will be measured in the intervention group using the System Usability Scale (SUS) at 6 months after randomisation 8. Experiences of participating in the trial will be explored using semi-structured interviews using a topic guide based on the theoretical constructs of acceptability at 6 months after randomisation 9. Healthcare professionals' experiences of delivering and supporting the intervention will be explored using semi-structured interviews using a topic guide based on the theoretical constructs of acceptability at 6 months after randomisation

Countries

England, United Kingdom

Contacts

Public ContactLouise Stayt
lstayt@brookes.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026