Impact of Nursing Intervention in Kidney Transplant Recipients Adherence

NCT05715580 | Unknown

• 1 other identifier: 22/325-EC_X
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this clinical trial is to analyse the impact of an informative nursing intervention in the adherence to drug treatment and a healthy lifestyle in kidney transplant patients and the effect of poor adherence on clinical predictors of poor kidney function. The main question\[s\] it aims to answer are:

• Is it possible improve the drug adherence of kidney recipients with a nursing information intervention?
• Is it possible improve the healthy lifestyle adherence of kidney recipients with a nursing information intervention? Participants will be divided into two groups: Intervention group: in which a health education action will be carried out and Control group in which the usual clinical practice will be maintained.

Conditions

Kidney Transplant; Complications

Keywords

Kidney transplantation; Treatment adherence and compliance; Clinical trial; Health Education

Outcome Measures

Primary Outcomes (1)

• Changes in Adherence to prescribed medication

  Measured by the Morisky-Green test

  Basal, 6 and 12 months after the basal

Secondary Outcomes (6)

• Changes in Adherence to physical exercise

  Basal, 6 and 12 months after the basal

• Changes in Adherence to healthy food

  Basal, 6 and 12 months after the basal

• Changes in alcohol consumption

  Basal, 6 and 12 months after the basal

• Changes in tobacco consumption

  Basal, 6 and 12 months after the basal

• Changes in Presence of emotional well-being

  Basal, 6 and 12 months after the basal

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The nursing intervention will consist of providing information to the patient with a KT about the importance of following the prescribed therapeutic regimen, at the same time the information they may have about healthy lifestyle habits will be expanded, with special emphasis on those areas in which there has been detected, through the administered questionnaires, a lack of adherence.

Other: Nursing information with a Protocol

Control group

PLACEBO COMPARATOR

The control group will be informed of the same aspects following the usual clinical practice, which consists of providing the information in the immediate post-transplant period, and resolving any doubts that the patient may have during the subsequent time.

Other: Usual clinical practice

Interventions

Nursing information with a Protocol OTHER

The nursing intervention will consist of providing information to the patient with a kidney transplant. To do this, a Committee of experts, made up of the 6 nurses from the kidney transplant Consultations of the Community of Madrid (Spain), will carry out an Information Protocol for adults with a kidney transplant, which will cover the healthy lifestyle habits described by the bibliography

Intervention group

Usual clinical practice OTHER

Nursing information following the usual clinical practice

Control group

Eligibility Criteria

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

You may qualify if:

• Have a kidney transplant
• Agree to participate

You may not qualify if:

• If the habitual residence is not in Madrid
• Those whose review frequency in the Kidney Transplant Consultation is planned for more than 6 months
• Pre-transplant hyperimmunized patients (Presence of preformed antibodies \>75%)
• Those who are not qualified to give their informed consent
• Those who do not read or understand the document well Spanish

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (5)

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (50)

• Memoria de Actividad de donación y trasplante renal España 2020 [Internet]. 2020. Available from: http://www.ont.es/infesp/Memorias/ACTIVIDAD DE DONACIÓN Y TRASPLANTE RENAL ESPAÑA 2020.pdf

  BACKGROUND

• World Health Organization. Adherence to long-term therapies : evidence for action / [edited by Eduardo Sabaté] [Internet]. Geneva PP - Geneva: World Health Organization; Available from: https://apps.who.int/iris/handle/10665/42682

  BACKGROUND

• Lopez V, Hernandez D, Gonzales M. Resultados globales del trasplante renal | Nefrología al día. Nefrol al Dia [Internet]. 2021;3:1-12. Available from: https://www.nefrologiaaldia.org/es-articulo-resultados-globales-del-trasplante-renal-58

  BACKGROUND

• Foundation NK. Nutrition and Transplant [Internet]. 2022 [cited 2022 Jan 18]. Available from: https://www.kidney.org/nutrition/transplant

  BACKGROUND

• Estrategia de promoción de la salud y prevención en el SNS [Internet]. Madrid; Available from: https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/Estrategia/docs/EstrategiaPromocionSaludyPrevencionSNS.pdf

  BACKGROUND

• El said SH, El Hoseiny S, El Raouf A, El Dahashan KF, Gad R, El Kader A. Lifestyle Modification among Post Renal Transplant Recipient. IOSR J Nurs Heal Sci. 2017;06(03):92-113

  BACKGROUND

• Pagès-Puigdemont N, Valverde-Merino MI. Métodos para medir la adherencia terapeútica. Ars Pharm. 2018;59(3):163-72.

  BACKGROUND

• CKD Group. Kidney Disease: Improving Global Outcomes (KDIGO). Kidney int. 2012;3(2013):1-150

  BACKGROUND

• Tan X, Patel I, Chang J. Review of the four item Morisky Medication Adherence Scale (MMAS-4) and eight item Morisky Medication Adherence Sacle (MMAS-8). Inov Pharm. 2014;5(3):165.

  BACKGROUND

• Staehr Johansen K. The use of well-being measures in primary health care - the DepCare project. 1998.

  BACKGROUND

• World Health Organisation. Wellbeing Measures in Primary Health Care/ The Depcare Project. Rep a WHO Meet [Internet]. 1998;45. Available from: http://www.euro.who.int/__data/assets/pdf_file/0016/130750/E60246.pdf

  BACKGROUND

• Meier-Kriesche HU, Ojo AO, Port FK, Arndorfer JA, Cibrik DM, Kaplan B. Survival improvement among patients with end-stage renal disease: trends over time for transplant recipients and wait-listed patients. J Am Soc Nephrol. 2001 Jun;12(6):1293-1296. doi: 10.1681/ASN.V1261293.

  PMID: 11373354 RESULT

• Thiruchelvam PT, Willicombe M, Hakim N, Taube D, Papalois V. Renal transplantation. BMJ. 2011 Nov 14;343:d7300. doi: 10.1136/bmj.d7300. No abstract available.

  PMID: 22084316 RESULT

• Senanayake S, Graves N, Healy H, Baboolal K, Barnett A, Sypek MP, Kularatna S. Donor Kidney Quality and Transplant Outcome: An Economic Evaluation of Contemporary Practice. Value Health. 2020 Dec;23(12):1561-1569. doi: 10.1016/j.jval.2020.07.007. Epub 2020 Sep 15.

  PMID: 33248511 RESULT

• Pascazio L, Nardone IB, Clarici A, Enzmann G, Grignetti M, Panzetta GO, Vecchiet C. Anxiety, depression and emotional profile in renal transplant recipients and healthy subjects: a comparative study. Transplant Proc. 2010 Nov;42(9):3586-90. doi: 10.1016/j.transproceed.2010.08.056.

  PMID: 21094820 RESULT

• Oniscu GC, Brown H, Forsythe JL. How great is the survival advantage of transplantation over dialysis in elderly patients? Nephrol Dial Transplant. 2004 Apr;19(4):945-51. doi: 10.1093/ndt/gfh022.

  PMID: 15031354 RESULT

• Kenawy AS, Gheith O, Al-Otaibi T, Othman N, Abo Atya H, Al-Otaibi M, Nagy MS. Medication compliance and lifestyle adherence in renal transplant recipients in Kuwait. Patient Prefer Adherence. 2019 Aug 30;13:1477-1486. doi: 10.2147/PPA.S209212. eCollection 2019.

  PMID: 31564836 RESULT

• Belaiche S, Decaudin B, Dharancy S, Noel C, Odou P, Hazzan M. Factors relevant to medication non-adherence in kidney transplant: a systematic review. Int J Clin Pharm. 2017 Jun;39(3):582-593. doi: 10.1007/s11096-017-0436-4. Epub 2017 Apr 3.

  PMID: 28374343 RESULT

• Couzi L, Moulin B, Morin MP, Albano L, Godin M, Barrou B, Alamartine E, Morelon E, Girardot-Seguin S, Mendes L, Misdrahi D, Cassuto E, Merville P. Factors predictive of medication nonadherence after renal transplantation: a French observational study. Transplantation. 2013 Jan 27;95(2):326-32. doi: 10.1097/TP.0b013e318271d7c1.

  PMID: 23149477 RESULT

• Hedayati P, Shahgholian N, Ghadami A. Nonadherence Behaviors and Some Related Factors in Kidney Transplant Recipients. Iran J Nurs Midwifery Res. 2017 Mar-Apr;22(2):97-101. doi: 10.4103/ijnmr.IJNMR_220_15.

  PMID: 28584545 RESULT

• Mathis AS. Managed care implications of improving long-term outcomes in organ transplantation. Am J Manag Care. 2015 Jan;21(1 Suppl):s24-30.

  PMID: 25734417 RESULT

• Dew MA, Dabbs AD, Myaskovsky L, Shyu S, Shellmer DA, DiMartini AF, Steel J, Unruh M, Switzer GE, Shapiro R, Greenhouse JB. Meta-analysis of medical regimen adherence outcomes in pediatric solid organ transplantation. Transplantation. 2009 Sep 15;88(5):736-46. doi: 10.1097/TP.0b013e3181b2a0e0.

  PMID: 19741474 RESULT

• Brahm MM, Manfro RC, Mello D, Cioato S, Goncalves LF. Evaluation of adherence to immunosuppressive drugs in kidney transplantation by control of medication dispensing. Transplant Proc. 2012 Oct;44(8):2391-3. doi: 10.1016/j.transproceed.2012.08.001.

  PMID: 23026602 RESULT

• Hardinger KL, Hutcherson T, Preston D, Murillo D. Influence of pill burden and drug cost on renal function after transplantation. Pharmacotherapy. 2012 May;32(5):427-32. doi: 10.1002/j.1875-9114.2012.01032.x. Epub 2012 Mar 30.

  PMID: 22467382 RESULT

• Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x.

  PMID: 19843035 RESULT

• Spivey CA, Chisholm-Burns MA, Damadzadeh B, Billheimer D. Determining the effect of immunosuppressant adherence on graft failure risk among renal transplant recipients. Clin Transplant. 2014 Jan;28(1):96-104. doi: 10.1111/ctr.12283. Epub 2013 Dec 11.

  PMID: 24329814 RESULT

• Nassir BA, Dean CE, Li S, Salkowski N, Solid CA, Schnitzler MA, Snyder JJ, Kim SJ, Kasiske BL, Linzer M, Israni AK. Variation in Cost and Quality in Kidney Transplantation. Transplantation. 2015 Oct;99(10):2150-7. doi: 10.1097/TP.0000000000000721.

  PMID: 25839707 RESULT

• Hugon A, Roustit M, Lehmann A, Saint-Raymond C, Borrel E, Hilleret MN, Malvezzi P, Bedouch P, Pansu P, Allenet B. Influence of intention to adhere, beliefs and satisfaction about medicines on adherence in solid organ transplant recipients. Transplantation. 2014 Jul 27;98(2):222-8. doi: 10.1097/TP.0000000000000221.

  PMID: 24926826 RESULT

• Nowicka M, Gorska M, Nowicka Z, Edyko K, Gozdzik M, Kurnatowska I. Adherence to Pharmacotherapy and Lifestyle Recommendations Among Hemodialyzed Patients and Kidney Transplant Recipients. J Ren Nutr. 2021 Sep;31(5):503-511. doi: 10.1053/j.jrn.2020.12.006. Epub 2021 Feb 26.

  PMID: 33642185 RESULT

• Takahashi A, Hu SL, Bostom A. Physical Activity in Kidney Transplant Recipients: A Review. Am J Kidney Dis. 2018 Sep;72(3):433-443. doi: 10.1053/j.ajkd.2017.12.005. Epub 2018 Feb 23.

  PMID: 29482935 RESULT

• Ronco C, Mason G, Nayak Karopadi A, Milburn A, Hegbrant J. Healthcare systems and chronic kidney disease: putting the patient in control. Nephrol Dial Transplant. 2014 May;29(5):958-63. doi: 10.1093/ndt/gft457. Epub 2013 Nov 13.

  PMID: 24235080 RESULT

• Calella P, Hernandez-Sanchez S, Garofalo C, Ruiz JR, Carrero JJ, Bellizzi V. Exercise training in kidney transplant recipients: a systematic review. J Nephrol. 2019 Aug;32(4):567-579. doi: 10.1007/s40620-019-00583-5. Epub 2019 Jan 16.

  PMID: 30649716 RESULT

• Li Y, Pan A, Wang DD, Liu X, Dhana K, Franco OH, Kaptoge S, Di Angelantonio E, Stampfer M, Willett WC, Hu FB. Impact of Healthy Lifestyle Factors on Life Expectancies in the US Population. Circulation. 2018 Jul 24;138(4):345-355. doi: 10.1161/CIRCULATIONAHA.117.032047.

  PMID: 29712712 RESULT

• Taber DJ, Fleming JN, Fominaya CE, Gebregziabher M, Hunt KJ, Srinivas TR, Baliga PK, McGillicuddy JW, Egede LE. The Impact of Health Care Appointment Non-Adherence on Graft Outcomes in Kidney Transplantation. Am J Nephrol. 2017;45(1):91-98. doi: 10.1159/000453554. Epub 2016 Dec 2.

  PMID: 27907919 RESULT

• Lin SY, Fetzer SJ, Lee PC, Chen CH. Predicting adherence to health care recommendations using health promotion behaviours in kidney transplant recipients within 1-5 years post-transplant. J Clin Nurs. 2011 Dec;20(23-24):3313-21. doi: 10.1111/j.1365-2702.2011.03757.x. Epub 2011 Jul 13.

  PMID: 21749509 RESULT

• Totti V, Campione T, Mosconi G, Tame M, Tonioli M, Gregorini M, Scarpioni R, Storari A, Mignani R, Sella G, Bellis L, Cardillo M, Sangiorgi G. Observational Retrospective Study on Patient Lifestyle in the Pretransplantation and Post-transplantation Period in the Emilia-Romagna Region. Transplant Proc. 2020 Jun;52(5):1552-1555. doi: 10.1016/j.transproceed.2020.03.015. Epub 2020 May 10.

  PMID: 32402457 RESULT

• Totti V, Campione T, Mosconi G, Tame M, Todeschini P, Sella G, Roi GS, Spazzoli A, Angelini ML, Sangiorgi G, Giannini A, Bellis L, Nanni Costa A. Promotion of Pre- and Post-Transplant Physical Exercise in the Emilia-Romagna Region: The Network of the Program "Transplantation, Physical Activity, and Sport". Transplant Proc. 2019 Nov;51(9):2902-2905. doi: 10.1016/j.transproceed.2019.02.074. Epub 2019 Oct 9.

  PMID: 31606183 RESULT

• Van Loon E, Bernards J, Van Craenenbroeck AH, Naesens M. The Causes of Kidney Allograft Failure: More Than Alloimmunity. A Viewpoint Article. Transplantation. 2020 Feb;104(2):e46-e56. doi: 10.1097/TP.0000000000003012.

  PMID: 32000235 RESULT

• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 RESULT

• Perez-Escamilla B, Franco-Trigo L, Moullin JC, Martinez-Martinez F, Garcia-Corpas JP. Identification of validated questionnaires to measure adherence to pharmacological antihypertensive treatments. Patient Prefer Adherence. 2015 Apr 13;9:569-78. doi: 10.2147/PPA.S76139. eCollection 2015.

  PMID: 25926723 RESULT

• Culig J, Leppee M. From Morisky to Hill-bone; self-reports scales for measuring adherence to medication. Coll Antropol. 2014 Mar;38(1):55-62.

  PMID: 24851597 RESULT

• Marshall AL, Smith BJ, Bauman AE, Kaur S. Reliability and validity of a brief physical activity assessment for use by family doctors. Br J Sports Med. 2005 May;39(5):294-7; discussion 294-7. doi: 10.1136/bjsm.2004.013771.

  PMID: 15849294 RESULT

• Sanders-Pinheiro H, Colugnati FAB, Marsicano EO, De Geest S, Medina JOP; Adhere Brazil Consortium Group. Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol. BMC Nephrol. 2018 Feb 20;19(1):41. doi: 10.1186/s12882-018-0840-6.

  PMID: 29463231 RESULT

• Puig Ribera A, Pena Chimenis O, Romaguera Bosch M, Duran Bellido E, Heras Tebar A, Sola Gonfaus M, Sarmiento Cruz M, Cid Cantarero A. [How to identify physical inactivity in primary care: validation of the Catalan and Spanish versions of 2 short questionnaires]. Aten Primaria. 2012 Aug;44(8):485-93. doi: 10.1016/j.aprim.2012.01.005. Epub 2012 Mar 29. Spanish.

  PMID: 22463945 RESULT

• Berben L, Denhaerynck K, Dobbels F, Engberg S, Vanhaecke J, Crespo-Leiro MG, Russell CL, De Geest S; BRIGHT study consortium. Building research initiative group: chronic illness management and adherence in transplantation (BRIGHT) study: study protocol. J Adv Nurs. 2015 Mar;71(3):642-54. doi: 10.1111/jan.12519. Epub 2014 Sep 26.

  PMID: 25257974 RESULT

• Ichimaru N, Nakazawa S, Yamanaka K, Kakuta Y, Abe T, Kaimori JY, Imamura R, Nonomura N, Takahara S. Adherence to Dietary Recommendations in Maintenance Phase Kidney Transplant Patients. Transplant Proc. 2016 Apr;48(3):890-2. doi: 10.1016/j.transproceed.2015.12.129.

  PMID: 27234760 RESULT

• Hall T, Krahn GL, Horner-Johnson W, Lamb G; Rehabilitation Research and Training Center Expert Panel on Health Measurement. Examining functional content in widely used Health-Related Quality of Life scales. Rehabil Psychol. 2011 May;56(2):94-99. doi: 10.1037/a0023054.

  PMID: 21574727 RESULT

• Neipp M, Karavul B, Jackobs S, Meyer zu Vilsendorf A, Richter N, Becker T, Schwarz A, Klempnauer J. Quality of life in adult transplant recipients more than 15 years after kidney transplantation. Transplantation. 2006 Jun 27;81(12):1640-4. doi: 10.1097/01.tp.0000226070.74443.fb.

  PMID: 16794528 RESULT

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 RESULT

• Faraldo-Cabana A, Sanchez-Fructuoso A, Perez-Flores I, Beneit-Montesinos JV, Munoz-Jimenez D, Peix Jimenez B, Asensio Arredondo S, Nuno Santana EI, Santana Valeros MJ, Hidalgo Gonzalez V, Gonzalez Garcia F, Ortuno-Soriano I. Development of an Information Guideline for Kidney Transplant Recipients in a Clinical Trial: Protocol for a Modified Delphi Method. JMIR Res Protoc. 2023 Nov 6;12:e46961. doi: 10.2196/46961.

  PMID: 37930773 DERIVED

MeSH Terms

Conditions

Treatment Adherence and Compliance; Health Education

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care

Study Officials

• Araceli Faraldo Cabana, Nurse

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Araceli Faraldo Cabana, Nurse

CONTACT

+34913303000; a_faraldo@hotmail.com

Ismael Ortuño Soriano, Nurse

CONTACT

+34913303000; iortuno@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Principal

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 8, 2023
• Study Start: April 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)