Technology Assisted Stepped Collaborative Care Intervention (TASCCI)
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|ClinicalTrials.gov Identifier: NCT03440853|
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|End-Stage Renal Disease Hemodialysis||Behavioral: TASCCI Other: Technology Delivered Health Education Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized 1:1 to TASCCI or technology-delivered health education and undergo a 12-week intervention. Psychological and clinical outcomes will be collected at baseline, post intervention, 6 and 12 months.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Patient reported outcomes will be administered centrally by blinded interviewers using computer-assisted telephone interviewing (CATI).|
|Official Title:||Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients|
|Actual Study Start Date :||March 28, 2018|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Patients randomized to TASCCI will receive a stepped-care approach of pharmaco and/or behavioral therapy for 12 weeks. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference.
TASCCI is a stepped-care collaborative care approach of pharmaco- and/or behavioral-therapy for a 12 week period. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. A trained behavioral therapist will deliver weekly video conferencing sessions during dialysis treatment.
Technology Delivered Health Education
Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis.
Other: Technology Delivered Health Education Intervention
The Technology Delivered Health Education Intervention will deliver weekly video conferencing sessions to deliver online educational material from the National Kidney Foundation. These sessions will be delivered by a care coordinator.
- Change in depression from baseline to 12 weeks [ Time Frame: Baseline and Post 12 week intervention ]Depressive symptoms will be measured using the Beck Depression Inventory-II
- Change in pain from baseline to 12 weeks [ Time Frame: Baseline and Post 12 week intervention ]Pain symptoms will be measured using the Brief Pain Inventory
- Change in fatigue from baseline to 12 weeks [ Time Frame: Baseline and Post 12 week intervention ]Fatigue symptoms will be measured using the FACIT-F
- Change in adherence to medications [ Time Frame: Baseline, 3 month, 6 month, 12 month ]Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine
- Change in adherence to fluid restriction [ Time Frame: Baseline, 3 month, 6 month, 12 month ]Fluid restriction adherence will be determined by inter-dialytic weight gain percentage (of post dialysis weight over preceding 1 month) obtained by reviewing dialysis records. Those with IDWG% >3.5% will be classified as non-adherent
- Change in adherence to hemodialysis treatments [ Time Frame: Baseline and Post 12 week intervention ]Non-adherence with dialysis will be defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12 week intervention period.
- To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-α) on biomarkers of inflammation [ Time Frame: Baseline and Post 12 week intervention, 6 month ]Effect of intervention on biomarkers of inflammation be measured by improvements in inflammatory cytokines.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440853
|Contact: Manisha Jhamb, MDfirstname.lastname@example.org|
|Contact: Mark Unruh, MD||MLUnruh@salud.unm.edu|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Manisha Jhamb, MD 412-647-7062 email@example.com|
|Contact: Melissa Weimer, MS 412-802-6739 firstname.lastname@example.org|
|Principal Investigator:||Manisha Jhamb, MD||University of Pittsburgh|