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

NCT03825770 | Completed

• 1 other identifier: 18-1657
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Fatigue; Energy conservation; Rehabilitation; Occupational therapy; End-stage renal disease; Chronic kidney disease; Hemodialysis; Disability; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (5)

• Fatigue Severity Scale

  From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention

• Fatigue Impact Scale

  From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention

• Fatigue Management Questionnaire

  From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention

• Reintegration to Normal Living Index

  From 1 week pre-intervention to 2 weeks mid-intervention, 1 week post-intervention, and 3 months post-intervention

• Canadian Occupational Performance Measure

  From 2 weeks mid-intervention to 1 week post-intervention, and 3 months post-intervention

Other Outcomes (1)

• Fidelity to treatment protocol

  From start to end of study intervention (approximately 10 weeks per participant)

Study Arms (2)

The "PEP" Program

EXPERIMENTAL

The "PEP" (Personal Energy Planning) Program

Behavioral: The "PEP" (Personal Energy Planning) Program

General Education

ACTIVE COMPARATOR

General Education about Kidney Disease

Behavioral: General Education about Kidney Disease

Interventions

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).

The "PEP" Program

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).

General Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

South Calgary Health Centre

Calgary, Alberta, T2X 3W5, Canada

Location

Related Publications (22)

• 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.

  PMID: 17200048 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.

  PMID: 17702730 BACKGROUND

• Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010 Mar;39(3):477-85. doi: 10.1016/j.jpainsymman.2009.08.008.

  PMID: 20303025 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.

  PMID: 29551585 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.

  PMID: 14730721 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.

  PMID: 24832095 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.

  PMID: 24694985 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.

  PMID: 16193899 BACKGROUND

• 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.

  PMID: 21561960 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.

  PMID: 12785670 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.

  PMID: 28698007 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.

  PMID: 28052703 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.

  PMID: 11345513 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.

  PMID: 11345506 BACKGROUND

• Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

  PMID: 2803071 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.

  PMID: 12474995 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.

  PMID: 23791482 BACKGROUND

• Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.

  PMID: 8148458 BACKGROUND

• 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. doi: 10.1177/000841749005700207.

  PMID: 10104738 BACKGROUND

• 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. doi: 10.1177/000841740407100406.

  PMID: 15586853 BACKGROUND

• Wood-Dauphinee SL, Opzoomer MA, Williams JI, Marchand B, Spitzer WO. Assessment of global function: The Reintegration to Normal Living Index. Arch Phys Med Rehabil. 1988 Aug;69(8):583-90.

  PMID: 3408328 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.

  PMID: 26092476 BACKGROUND

MeSH Terms

Conditions

Fatigue; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Brenda R Hemmelgarn, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head, Community Health Sciences

Model Details: 1:1 pilot randomized controlled trial. Participants will be randomized to intervention (energy conservation education) or active control (general information about kidney disease).

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 31, 2019
• Study Start: February 21, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)