Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Epi029 | Other Identifier | Epidemiology Group, University of Aberdeen |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Versus Arthritis | OTHER |
Not provided
Not provided
Not provided
Not provided
Fatigue is common and disabling for most patients with inflammatory rheumatic disease. Therapies designed to improve physical activity and 'talking' treatments, which positively help patients change the way they think and behave, are both helpful in reducing the burden of the fatigue. However, few patients have access to these treatments in most health services. This situation results from the absence of standardised programmes and limited availability of relevant therapists.
The investigators aim to enhance access to fatigue alleviating physical activity and talking therapies by testing innovative,standardised and cost-effective approaches to treatment delivery.
The investigators will also use this opportunity to understand how to select the best treatment for a patient based on their individual profile and to better understand how these treatments actually work. This in turn may lead to more refined and effective therapies in the future.
Eligible participants will be identified from patients with inflammatory rheumatic diseases attending major secondary care rheumatology services in the United Kingdom. Potential participants will be identified using local databases/clinic lists and will then be mailed a pre-study invite, which will include questions about fatigue. Potentially eligible participants will be invited to attend a baseline assessment.
Once it has been confirmed at the baseline assessement that they are eligible to take part in the study, the consented participant will be allocated to one of three treatment groups. During the course of the trial, the participant will be invited to visit the study centre three more times for assessments.
At each of the four assessment visits (baseline, and approximately 2, 7 and 13 months after) they will be asked:
All participants will be asked to keep a diary on any other treatments they are using in addition to the treatments they may receive during the study and how costly these other treatments are. The diary period will last for the first 6 months and then for 2 weeks after the third visit and 2 weeks before the last visit.
After they finished the study, the investigators may approach a subgroup of participants who received either the talking therapy or the personalised exercise programme again and ask for an interview to enable more detailed feedback on if they found the intervention helpful and how it has changed their daily life.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care alone | Active Comparator | Participants receive written information about fatigue which is designed as self-management guide. |
|
| CBA + usual care | Active Comparator | In addition to usual care, participants receive a talking therapy using a cognitive behavioural approach. The talking therapy will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 8 sessions over a period of 6 months. |
|
| PEP + usual care | Active Comparator | In addition to usual care, participants receive a personalised exercise programme. After an initial face-to-face assessment, the remaining programme will be delivered via telephone by a trained rheumatology health care professional who will contact the participant for 7 sessions over a period of 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Behavioral | Information booklet on fatigue which represents usual care in almost all UK rheumatology centres |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue (severity) using Chalder Fatigue Scale (Likert) | Chalder Fatigue Scale (Likert), assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks after randomisation, Main estimate of treatment effect at 56 weeks | 56 weeks |
| Fatigue (severity) using Chalder Fatigue Scale (Likert) | Chalder Fatigue Scale (Likert), assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC | 10 weeks |
| Fatigue (severity) using Chalder Fatigue Scale (Likert) | Chalder Fatigue Scale (Likert), assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC | 28 weeks |
| Fatigue (impact) using Fatigue Severity Scale | Fatigue Severity Scale, co-primary outcome assessed at 56 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC with main estimate of treatment effect at 56 weeks | 56 weeks |
| Fatigue (impact) using Fatigue Severity Scale | Fatigue Severity Scale, co-primary outcome assessed at 10 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC | 10 weeks |
| Fatigue (impact) using Fatigue Severity Scale | Fatigue Severity Scale, co-primary outcome assessed at 28 weeks after baseline, between-group change CBA+UC vs UC and PEP+UC vs UC | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue (physical, living, cognition and emotional aspects) using Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire | Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire | 0, 10 weeks, 28 weeks, 56 weeks after randomisation |
| Quality of life & health utility index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary Macfarlane, PhD | University of Aberdeen | Principal Investigator |
| Neil Basu, MBChB, PhD | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Grampian | Aberdeen | United Kingdom | ||||
| NHS Tayside |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39257857 | Derived | Gray SR, Montoye AHK, Vondrasek JD, Neph S, Siebert S, Paul L, Bachmair EM, Basu N. Associations of physical activity levels with fatigue in people with inflammatory rheumatic diseases in the LIFT trial. Rheumatol Adv Pract. 2024 Aug 24;8(3):rkae106. doi: 10.1093/rap/rkae106. eCollection 2024. | |
| 36388001 | Derived |
| Label | URL |
|---|---|
| Click here for more information about this study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 10, 2023 | |
| Reset | Jan 3, 2024 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2020 | Sep 6, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Cognitive behavioural approach | Behavioral | A talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities |
|
|
| Personalised Exercise Programme | Behavioral | PEP is a graded exposure behaviour therapy which aims to gradually optimise patients levels of physical activity with view to modifying their altered perception of effort and ultimately reduce the severity and impact of fatigue. |
|
|
SF-12 |
| 0, 10 weeks, 28 weeks, 56 weeks after randomisation |
| Pain using numerical rating scale | Pain numerical rating scale | 0, 10 weeks, 28 weeks, 56 weeks after randomisation |
| Anxiety and depression using Hospital anxiety and depression scale | Hospital anxiety and depression scale | 0, 10 weeks, 28 weeks, 56 weeks after randomisation |
| Impact on work using Work Productivity and Activity Impairment Questionnaire | Work Productivity and Activity Impairment Questionnaire: Specific Health Problem | 0, 10 weeks, 28 weeks, 56 weeks after randomisation |
| Impact on activities using Valued Life Activities Scale | Valued Life Activities Scale | 0, 10 weeks, 28 weeks, 56 weeks after randomisation |
| Change of global health | Single question to indicate perceived change in global health compared with last assessment visit | 10 weeks, 28 weeks, 56 weeks after randomisation |
| Dundee |
| United Kingdom |
| NHS Lothian | Edinburgh | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | United Kingdom |
| Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Midlands Partnership NHS Foundation Trust | Stoke-on-Trent | ST6 7AG | United Kingdom |
| Bachmair EM, Martin K, Aucott L, Dhaun N, Dures E, Emsley R, Gray SR, Kidd E, Kumar V, Lovell K, MacLennan G, McNamee P, Norrie J, Paul L, Packham J, Ralston SH, Siebert S, Wearden A, Macfarlane G, Basu N; LIFT study group. Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial. Lancet Rheumatol. 2022 Jun 27;4(8):e534-e545. doi: 10.1016/S2665-9913(22)00156-4. eCollection 2022 Aug. |
| 30705244 | Derived | Martin KR, Bachmair EM, Aucott L, Dures E, Emsley R, Gray SR, Hewlett S, Kumar V, Lovell K, Macfarlane GJ, MacLennan G, McNamee P, Norrie J, Paul L, Ralston S, Siebert S, Wearden A, White PD, Basu N. Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT). BMJ Open. 2019 Jan 30;9(1):e026793. doi: 10.1136/bmjopen-2018-026793. |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2021 | Sep 6, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2018 | Sep 6, 2021 | ICF_003.pdf |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2023 | Jan 3, 2024 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D008180 | Lupus Erythematosus, Systemic |
| D000089183 | Axial Spondyloarthritis |
| D015535 | Arthritis, Psoriatic |
| D012859 | Sjogren's Syndrome |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided