TY - JOUR
T1 - Rationale and design of technology assisted stepped collaborative care intervention to improve patient-centered outcomes in hemodialysis patients (TĀCcare trial)
AU - Roumelioti, Maria Eleni
AU - Steel, Jennifer L.
AU - Yabes, Jonathan
AU - Vowles, Kevin E.
AU - Vodovotz, Yoram
AU - Beach, Scott
AU - Rollman, Bruce
AU - Weisbord, Steven D.
AU - Unruh, Mark L.
AU - Jhamb, Manisha
N1 - Funding Information:
This work is supported by NIH/NIDDK 1R01DK114085 (PI, Jhamb).
Publisher Copyright:
© 2018 The Authors
PY - 2018/10
Y1 - 2018/10
N2 - Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. non-adherence to medication and dialysis) and biological factors (e.g. inflammatory cytokines). Prior interventions to alleviate symptoms and improve HRQOL showed limited effectiveness in HD patients and their effect on bio-behavioral mediators is lacking evidence. It is imperative to improve patient-centered dialysis care and to address call from Kidney Disease Improving Global Outcomes (KDIGO) guidelines for integration of symptom assessment and management in routine HD-care. Technology-Assisted stepped Collaborative Care (TĀCcare) is a multi-center randomized controlled trial (RCT) of 150 diverse HD patients from Pennsylvania and New Mexico, designed to compare the effectiveness of a 12-week stepped collaborative care intervention (cognitive behavioral therapy, CBT) with an attention control arm of technology-delivered health education. Collaborative care provides an integrated multi-disciplinary structured management plan. Furthermore, a stepped approach to pharmacotherapy and/or CBT allows for individualization of treatment according to patients’ clinical status, preferences and treatment response. To simplify the delivery of CBT and to minimize patient and provider burden, we will use live video-conferencing with patients in dialysis units. We will examine the effect of these interventions on patient symptoms, HRQOL, treatment adherence and inflammatory biomarkers. This RCT tests a readily implementable intervention that can be integrated in routine HD-care and will generate novel and meaningful insights on strategies to alleviate common symptoms and improve HRQOL in HD.
AB - Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. non-adherence to medication and dialysis) and biological factors (e.g. inflammatory cytokines). Prior interventions to alleviate symptoms and improve HRQOL showed limited effectiveness in HD patients and their effect on bio-behavioral mediators is lacking evidence. It is imperative to improve patient-centered dialysis care and to address call from Kidney Disease Improving Global Outcomes (KDIGO) guidelines for integration of symptom assessment and management in routine HD-care. Technology-Assisted stepped Collaborative Care (TĀCcare) is a multi-center randomized controlled trial (RCT) of 150 diverse HD patients from Pennsylvania and New Mexico, designed to compare the effectiveness of a 12-week stepped collaborative care intervention (cognitive behavioral therapy, CBT) with an attention control arm of technology-delivered health education. Collaborative care provides an integrated multi-disciplinary structured management plan. Furthermore, a stepped approach to pharmacotherapy and/or CBT allows for individualization of treatment according to patients’ clinical status, preferences and treatment response. To simplify the delivery of CBT and to minimize patient and provider burden, we will use live video-conferencing with patients in dialysis units. We will examine the effect of these interventions on patient symptoms, HRQOL, treatment adherence and inflammatory biomarkers. This RCT tests a readily implementable intervention that can be integrated in routine HD-care and will generate novel and meaningful insights on strategies to alleviate common symptoms and improve HRQOL in HD.
KW - Depression
KW - Fatigue
KW - Hemodialysis patients
KW - Pain
KW - Patient-centered Outcomes
KW - Symptoms
UR - http://www.scopus.com/inward/record.url?scp=85053389187&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2018.09.002
DO - 10.1016/j.cct.2018.09.002
M3 - Article
C2 - 30208343
AN - SCOPUS:85053389187
SN - 1551-7144
VL - 73
SP - 81
EP - 91
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -