Pilot Study of an Educational Program for Adults on Hemodialysis With Fatigue

Quality of Life Clinical Trial

— Fatigue-HD  

Official title:

A Pilot Randomized Controlled Trial of an Educational Program for Adults on Hemodialysis With Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825770
• Other study ID #: 18-1657
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: April 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. To estimate the proportion of ESRD patients that are eligible for the RCT, will consent to participate, and will complete all study procedures

2. To identify the optimal primary outcome for the RCT and estimate the treatment effect size for RCT sample size calculations

3. To examine treatment fidelity to the PEP program among non-rehabilitation staff who undergo program administration training

4. To explore the effects of the PEP program on fatigue and disability at 3 months post-treatment

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged =18 years

• On chronic dialysis therapy for =3 months at time of recruitment

• Clinically and cognitively stable (able to provide informed consent)

• Scores an avg. of =4 on items 5, 7 , 8 and 9 of the Fatigue Severity Scale

Exclusion Criteria:

• Inadequate written and verbal English comprehension for study activities

• Plan in place to discontinue in-center hemodialysis at the participating center within 6 months of the time of recruitment (due to modality change, relocation, transplantation, or dialysis withdrawal)

• Resides in a nursing home facility

• Significant visual impairment (ie. unable to read size 14-pt font, Times New Roman)

• Scores >3 on Personal Health Questionnaire 2 (PHQ-2) depression screening tool

Related Conditions & MeSH terms

• Fatigue
• Kidney Diseases
• Quality of Life
• Rehabilitation
• Renal Dialysis

Intervention

Behavioral:
• The "PEP" (Personal Energy Planning) Program
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).
• General Education about Kidney Disease
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).

Locations

Country	Name	City	State
Canada	South Calgary Health Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (22)

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Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. Review. — View Citation

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Finlayson M, Preissner K, Cho C, Plow M. Randomized trial of a teleconference-delivered fatigue management program for people with multiple sclerosis. Mult Scler. 2011 Sep;17(9):1130-40. doi: 10.1177/1352458511404272. Epub 2011 May 11. — View Citation

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Flachenecker P, Kümpfel 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Norberg EB, Löfgren B, Boman K, Wennberg P, Brännström 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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	Eligibility rate	The proportion of patients screened who are eligible for the study	From start to end of study screening (approximately 9 months)
Primary	Recruitment rate	The proportion of patients eligible for the study who consent to participate	From start to end of study recruitment (approximately 9 months)
Primary	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)
Secondary	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
Secondary	Fatigue Impact Scale	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
Secondary	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
Secondary	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
Secondary	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