A phase II pilot randomized controlled trial of an integrated stepped collaborative care intervention for patients awaiting kidney transplantation (CARES-transplant).
Patients awaiting kidney transplant carry a high symptom burden which has been associated with waitlist inactivation, mortality, and poorer post-transplant outcomes. However, few studies have tested the effects of symptom management interventions in this population. This Phase II study aimed to (1)...
| Publicado en: | Journal of Behavioral Medicine Vol. 48; no. 5; pp. 731 - 745 |
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| Autores principales: | , , , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Springer Nature
Oct2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188313295&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188313295 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01607715 JBM jtl: Journal of Behavioral Medicine issn: 01607715 maglogo: N pubinfo: dt: Oct2025 vid: 48 iid: 5 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 188313295 186560423 188313295 188313295 10.1007/s10865-025-00574-x 188313295 ppf: 731 ppct: 14 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: A phase II pilot randomized controlled trial of an integrated stepped collaborative care intervention for patients awaiting kidney transplantation (CARES-transplant). aug: au: Kallem, Cramer J. Tevar, Amit A. Bradley, Tyler Jackson, Heather Haggerty, Denise Cheng, Hannah Pathak, Ritambhara Wang, Yisi Carney, Maureen Gardner, Shelby Deshpande, Athrva Jhamb, Manisha Steel, Jennifer L. affil: https://ror.org/01an3r305 Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA sug: subj: Kidney Transplantation Transplant Recipients Psychosocial Factors Waiting Lists Signs and Symptoms Prevention and Control Health Care Delivery, Integrated Outcomes (Health Care) Evaluation Health Resource Utilization Evaluation Caregiver Attitudes Evaluation Human Male Female Middle Age Aged Randomized Controlled Trials Random Assignment Questionnaires Pain Management Fatigue Prevention and Control Fatigue Depression Prevention and Control Postoperative Complications Prevention and Control Emergency Room Visits Readmission Quality of Life Descriptive Statistics Data Analysis Software Repeated Measures Analysis of Variance T-Tests Chi Square Test Brief Pain Inventory Center for Epidemiological Studies Depression Scale Clinical Assessment Tools Psychological Tests Scales Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Patients awaiting kidney transplant carry a high symptom burden which has been associated with waitlist inactivation, mortality, and poorer post-transplant outcomes. However, few studies have tested the effects of symptom management interventions in this population. This Phase II study aimed to (1) test the feasibility and preliminary efficacy of an integrated stepped collaborative care intervention (CARES-Transplant) on patient-reported outcomes and unplanned healthcare utilization, and (2) explore treatment effects on family caregiver outcomes. The study was a randomized controlled trial designed to test the efficacy of CARES-Transplant versus standard of care (SC). Patients completed a battery of questionnaires at baseline and 3-months including the Center for Epidemiological Studies-Depression (CES-D) scale, Brief Pain Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue, and Rand Short Form-36. Caregivers were administered the CES-D, Perceived Stress Scale, and Pittsburgh Sleep Quality Index at baseline and 3-months. Patient unplanned health care utilization was assessed over the course of one-year post-randomization. Nineteen patients (mean age = 65 ± 6 years, 74% male, 90% White) and 8 caregivers (mean age = 61.3 ± 8.1 years, 100% female and white) were randomized. Reductions in pain intensity and interference were observed for CARES (− 0.2) while patients in the SC arm had increases in pain intensity and interference (+ 1.3, ES = 0.30). Similar trends were observed for fatigue (CARES = − 0.4 versus SC = − 7.7, ES = 0.41) and depressive symptoms (CARES = − 2.0 versus SC = + 2.33, ES = 0.56). Lower rates of transplant-related complications (CARES mean = 1 versus SC = 3), fewer emergency room visits (CARES = 1.0 versus SC = 2.67) and 90-day readmissions (CARES = 0% versus SC = 28.6%) were also observed. A moderate to large effect size was observed for changes on caregiver reported depressive symptoms (CARES = + 0.5 versus SC = + 3.3, ES = 0.55) and sleep quality (CARES = − 1.5 versus SC = + 0.07, ES = 0.34). The findings of this pilot study warrant a Phase III trial to test the efficacy of CARES-Transplant. Clinical trials registration number ClinicalTrials.gov NCT02938351. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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