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Fatigue is a common and problematic symptom of end-stage renal disease (ESRD). The investigators have developed a new program, called the Personal Energy Planning (PEP) program, that teaches people with ESRD to manage fatigue by using energy conservation strategies during everyday life (eg. organization, prioritization, using good body postures and assistive tools). A large study is needed to test whether the program is helpful for people with ESRD. First, the investigators need to do a smaller-scale pilot study to help plan the large study. The main purposes of this pilot study are to see how many people with ESRD are willing and able to complete the PEP program, and to explore whether the program helps people feel less fatigued. The investigators plan to invite 40 people with ESRD from 4 dialysis units in Calgary, Alberta to participate. People with ESRD who report feeling unusually tired a lot of the time (using a symptom assessment tool completed every 2 months) will be asked to take part. Study participants will either do the PEP program, or another program (the control) that gives them general information about kidney disease. Participants will also be asked to complete questionnaires about fatigue before and after the study. The investigators will compare fatigue scores between the PEP program group and the control group, and record how many agree to take part in the study and complete all study activities. This pilot study will help the investigators plan next steps for research into the PEP program.
BACKGROUND: Fatigue is one of the most common, disabling, and distressing symptoms experienced by people with end-stage renal disease (ESRD; kidney failure). There are currently few evidence-based treatment options to address fatigue in the ESRD population. Energy conservation education (ECE) is a rehabilitative approach shown to improve fatigue-related outcomes in other chronic disease populations, that has yet to be studied in people with ESRD. The investigators recently developed a novel ECE program for people with ESRD, conducted acceptability and usability testing, and showed improvements in fatigue and disability in single-case studies. A large randomized controlled trial (RCT) is now required to establish the efficacy of the PEP program, but additional feasibility information is first needed to design the definitive RCT.
OBJECTIVES:
METHODS: Single-center, 1:1, parallel-arm pilot RCT. Adults on hemodialysis in Calgary at 4 dialysis units will be screened for eligibility. Prospective participants will be identified and approached by a clinical team member to assess their interest in the study. Interested patients will then be approached by a research team member to undergo informed consent and eligibility screening. Consenting participants will be randomized using a computer-generated randomization list and blocked randomization. Patients and outcome adjudicators will be blinded as to which is the treatment vs. control condition (blinding of providers is not feasible). Participants randomized to intervention will undergo the PEP energy conservation education program, consisting of two web modules and 4-7 sessions with a study clinician. Participants randomized to control will review the "Living with Kidney Disease" patient handbooks with a study clinician. Routine demographic and clinical data will be obtained at baseline, and the following measures will be administered to participants at baseline, mid-treatment, immediate post-treatment, and three months post-treatment: the Fatigue Severity Scale, Fatigue Impact Scale, Fatigue Management Questionnaire, Reintegration to Normal Living Index, and Canadian Occupational Performance Measure. A sample size of 40 patients (20 per arm) will provide an optimal estimate of treatment effect size for RCT sample size calculations, given 80% power, a small/medium effect size, and an attrition rate of ≤20%.
DATA ANALYSIS: The proportion of patients meeting each of the feasibility endpoints (eligibility, recruitment and attrition rates) will be calculated. Pre-to-post effect sizes will be calculated for all outcome measures used, and the outcome measure with the largest effect size will be chosen as the primary outcome for the RCT. Sample size calculations will then be made using the treatment effect size and variance from the pilot RCT data. Audio recordings of treatment sessions will be reviewed and rated using a Likert-scale rating system to estimate treatment fidelity. Effect sizes will also be calculated from pre-intervention to 3 months post-intervention.
IMPLICATIONS: Findings from this pilot RCT will help in the design of a robust RCT of the PEP program, which has the potential to improve fatigue management in the ESRD population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The "PEP" Program | Experimental | The "PEP" (Personal Energy Planning) Program |
|
| General Education | Active Comparator | General Education about Kidney Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The "PEP" (Personal Energy Planning) Program | Behavioral | The PEP program is designed to teach people on dialysis with fatigue how to conserve energy during day-to-day tasks, and how to use energy conservation to accomplish their goals. The program is delivered over 7-9 weekly sessions. It consists of 2 educational web modules about energy conservation, and 5-7 goal-focused training sessions with a study clinician that utilize a problem-solving training approach known as the Cognitive Orientation to Occupational Performance (CO-OP) approach. Each program session lasts ~20-30 mins. Sessions are completed either in person during hemodialysis, or via telephone (based on patient preference). The program is administered by a trained study clinician (occupational therapist or nurse). |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility rate | The proportion of patients screened who are eligible for the study | From start to end of study screening (approximately 9 months) |
| Recruitment rate | The proportion of patients eligible for the study who consent to participate | From start to end of study recruitment (approximately 9 months) |
| Attrition rate | The proportion of consenting patients who withdraw from the study before completing all study activities | From start to end of study data collection (approximately 15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale | A 9-item self-report questionnaire which measures the severity of fatigue and its impact on activities and lifestyle | From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention |
| Fatigue Impact Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity to treatment protocol | Adherence to PEP program protocol by program administrators, measured by the Co-op Fidelity Checklist | From start to end of study intervention (approximately 10 weeks per participant) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenda R Hemmelgarn, MD, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Calgary Health Centre | Calgary | Alberta | T2X 3W5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17200048 | Background | Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001. | |
| 17702730 | Background | Weisbord SD, Fried LF, Mor MK, Resnick AL, Unruh ML, Palevsky PM, Levenson DJ, Cooksey SH, Fine MJ, Kimmel PL, Arnold RM. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2007 Sep;2(5):960-7. doi: 10.2215/CJN.00990207. Epub 2007 Aug 8. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D007674 | Kidney Diseases |
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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1:1 pilot randomized controlled trial. Participants will be randomized to intervention (energy conservation education) or active control (general information about kidney disease).
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Study participants will be blinded as to which educational program is the "active" treatment under study. Patient study materials and communications will only describe the study as being about an educational program for adults on hemodialysis with fatigue.
|
| General Education about Kidney Disease | Behavioral | General education about kidney disease involves a review of information from the Kidney Foundation of Canada's patient handbooks "Living with Reduced Kidney Function" and "Living with Kidney Failure" (www.kidney.ca/manual) during 6-8 brief individual sessions with a trained study clinician (occupational therapist or nurse).The handbooks contains general information about managing kidney disease, addressing topics such as medication management, diet, and emotional well-being on dialysis. Sessions will take place either in person during hemodialysis, or via telephone (based on patient preference). |
|
A 21-item self-report questionnaire which assesses the effects of fatigue on physical, cognitive, and psychosocial functioning |
| From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention |
| Fatigue Management Questionnaire | A 5-item self-report questionnaire which assesses self-perceived competence at fatigue management | From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention |
| Reintegration to Normal Living Index | An 11-item self-report questionnaire which assesses the degree to which individuals who have experienced traumatic or incapacitating illness, achieve reintegration into normal social activities | From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention |
| Canadian Occupational Performance Measure | An outcome measure designed to capture a client's self-perception of performance in everyday living, over time | From 2 weeks mid-intervention to 1 week post-intervention, and 3 months post-intervention |
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| 29551585 | Background | Ju A, Unruh M, Davison S, Dapueto J, Dew MA, Fluck R, Germain M, Jassal SV, Obrador G, O'Donoghue D, Josephson MA, Craig JC, Viecelli A, O'Lone E, Hanson CS, Manns B, Sautenet B, Howell M, Reddy B, Wilkie C, Rutherford C, Tong A; SONG-HD Fatigue Workshop Collaborators. Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop Report. Am J Kidney Dis. 2018 Jul;72(1):104-112. doi: 10.1053/j.ajkd.2017.12.018. Epub 2018 Mar 16. |
| 14730721 | Background | Heiwe S, Clyne N, Dahlgren MA. Living with chronic renal failure: patients' experiences of their physical and functional capacity. Physiother Res Int. 2003;8(4):167-77. doi: 10.1002/pri.287. |
| 24832095 | Background | Manns B, Hemmelgarn B, Lillie E, Dip SC, Cyr A, Gladish M, Large C, Silverman H, Toth B, Wolfs W, Laupacis A. Setting research priorities for patients on or nearing dialysis. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1813-21. doi: 10.2215/CJN.01610214. Epub 2014 May 15. |
| 24694985 | Background | Artom M, Moss-Morris R, Caskey F, Chilcot J. Fatigue in advanced kidney disease. Kidney Int. 2014 Sep;86(3):497-505. doi: 10.1038/ki.2014.86. Epub 2014 Apr 2. |
| 16193899 | Background | Mathiowetz VG, Finlayson ML, Matuska KM, Chen HY, Luo P. Randomized controlled trial of an energy conservation course for persons with multiple sclerosis. Mult Scler. 2005 Oct;11(5):592-601. doi: 10.1191/1352458505ms1198oa. |
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| 12785670 | Background | Vanage SM, Gilbertson KK, Mathiowetz V. Effects of an energy conservation course on fatigue impact for persons with progressive multiple sclerosis. Am J Occup Ther. 2003 May-Jun;57(3):315-23. doi: 10.5014/ajot.57.3.315. |
| 28698007 | Background | Kim YJ, Rogers JC, Raina KD, Callaway CW, Rittenberger JC, Leibold ML, Holm MB. Solving fatigue-related problems with cardiac arrest survivors living in the community. Resuscitation. 2017 Sep;118:70-74. doi: 10.1016/j.resuscitation.2017.07.005. Epub 2017 Jul 8. |
| 28052703 | Background | Norberg EB, Lofgren B, Boman K, Wennberg P, Brannstrom M. A client-centred programme focusing energy conservation for people with heart failure. Scand J Occup Ther. 2017 Nov;24(6):455-467. doi: 10.1080/11038128.2016.1272631. Epub 2017 Jan 5. |
| 11345513 | Background | Missiuna C, Mandich AD, Polatajko HJ, Malloy-Miller T. Cognitive orientation to daily occupational performance (CO-OP): part I--theoretical foundations. Phys Occup Ther Pediatr. 2001;20(2-3):69-81. |
| 11345506 | Background | Polatajko HJ, Mandich AD, Missiuna C, Miller LT, Macnab JJ, Malloy-Miller T, Kinsella EA. Cognitive orientation to daily occupational performance (CO-OP): part III--the protocol in brief. Phys Occup Ther Pediatr. 2001;20(2-3):107-23. |
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| 12474995 | Background | Flachenecker P, Kumpfel T, Kallmann B, Gottschalk M, Grauer O, Rieckmann P, Trenkwalder C, Toyka KV. Fatigue in multiple sclerosis: a comparison of different rating scales and correlation to clinical parameters. Mult Scler. 2002 Dec;8(6):523-6. doi: 10.1191/1352458502ms839oa. |
| 23791482 | Background | Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20. |
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| 26092476 | Background | Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19. |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |