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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
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of New Mexico
Information provided by (Responsible Party):
Manisha Jhamb, University of Pittsburgh

Brief Summary:
This study evaluates a collaborative care intervention in reducing depression, fatigue and pain symptoms and improving health related quality of life in hemodialysis patients. Half of participants will receive the collaborative care intervention, while the other half will receive technology delivered health education information.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Hemodialysis Behavioral: TASCCI Other: Technology Delivered Health Education Intervention Not Applicable

Detailed Description:
End-stage renal disease patients on hemodialysis experience substantial symptom burden with fatigue, pain and depression among the most debilitating and existing as symptom clusters. These symptom clusters can exacerbate one another, and are independent and strong predictors of poor health-related quality of life in hemodialysis patients. This study will look at the effect of a 12 week stepped care intervention on changes in depression, pain or fatigue and health related quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
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).
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: TASCCI
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.
Behavioral: TASCCI
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years or older
  2. undergoing thrice-weekly maintenance hemodialysis for > 3 months
  3. English speaking
  4. able to provide informed consent
  5. no evidence of thought disorder, delusions or active suicidal ideation

Exclusion Criteria:

  1. thought disorder, delusions or active suicidal ideation
  2. active substance abuse
  3. too ill or cognitively impaired to participate based on clinicians' judgment
  4. anticipated life expectancy of less than 1 year
  5. unable or unwilling to adhere to study protocol
  6. participating in another clinical trial or taking an investigational drug
  7. scheduled for living donor kidney transplant within next 6 months
  8. relocating to another dialysis unit within 6 months

Information from the National Library of Medicine

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


Contacts
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Contact: Manisha Jhamb, MD 412-647-7062 jhambm@upmc.edu
Contact: Mark Unruh, MD MLUnruh@salud.unm.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Manisha Jhamb, MD    412-647-7062    jhambm@upmc.edu   
Contact: Melissa Weimer, MS    412-802-6739    weimermc@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of New Mexico
Investigators
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Principal Investigator: Manisha Jhamb, MD University of Pittsburgh

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Responsible Party: Manisha Jhamb, Associate Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03440853     History of Changes
Other Study ID Numbers: PRO17070630
1R01DK114085-01 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency