Fatigue‐HD 2019.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 12 weeks Time frame: February 2019 to August 2019
Participants	Study characteristics Setting: multicentre (6 dialysis clinics in Calgary) Country: Canada Inclusion criteria: aged ≥ 18 years; HD ≥ 3 months at the time of recruitment; were clinically and cognitively stable (able to provide informed consent) and scored an average of ≥ 4 on items 5, 7, 8 and 9 from the FSS, English‐speaking Exclusion criteria: plan in place to discontinue in‐centre HD within 6 months of recruitment; inadequate written and verbal English comprehension for study activities; if they resided in a long‐term care facility or if they had a visual impairment that would preclude them from engaging with study materials Baseline characteristics Number (analysed/randomised): intervention group (8/15); control group (14/15) Mean age ± SD (years): intervention group (60.0 ± 15.1); control group (64.8 ± 14.4) Sex (M/F): overall (18/12); intervention group (8/7); control group (10/5) Dialysis type: HD Mean dialysis vintage ± SD (years): not reported Comorbidities CVD: not reported Diabetes: intervention group (6/15); control group (9/15) Hypertension: not reported Depression (clinician diagnosis): intervention group (6/15); control group (3/15)
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group PEP programme Control group Education Co‐interventions Not reported
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Fatigue FSS: assessed at week 1 and 12 MFIS: assessed at week 1 and 12 (Appendix 3) SONG‐HD Fatigue (Appendix 3) Life participation COPM‐Performance Scale: assessed at week 1 and 12 (Appendix 3) Fatigue management questionnaire: assessed at week 1 and 12 (Appendix 3) COPM‐Satisfaction subscale: assessed at week 1 and 12 NLI: assessed at week 1 and 12 (Appendix 3)
Notes	Additional information Funding: Canadian Institutes of Health Research (CIHR) Fellowship Program, and the Kidney Research Scientist Core Education andNational Training (KRESCENT) programme Conflicts of interest/disclosures: none Trial registration identification number: NCT03825770 A priori published protocol was reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Participants were randomised using a computer‐generated random number sequence according to permuted blocked randomisation, stratified by dialysis unit." Comment: A computer‐generated random number sequence is considered as low risk of bias
Allocation concealment (selection bias)	Low risk	Quote: "We concealed allocation by having a research manager not otherwise involved with the study, provide treatment allocation to study coordinators over the phone."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Participants were blinded to treatment allocation. It was not feasible to blind study coordinators, given the extensive training they received to learn to administer the intervention compared with the control." Comment: A single blind study is considered as high risk of bias
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote from the study protocol: "As the proposed study is small and its risks to participants are low, a Data and Safety Monitoring Board is not needed." Comment: Fatigue was assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	High risk	8/15 participants in the intervention group and 14/15 participants in the control group completed the study (> 5% lost to follow‐up). There were differences between treatment groups. Reasons for discontinuation were provided
Selective reporting (reporting bias)	High risk	Protocol was published. Fatigue was reported in accordance with a pre‐specified analysis plan, using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was not extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	Low risk	There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. No other source of bias were apparent