Back to resultsTechnology Assisted Stepped Collaborative Care Intervention (TASCCI)
Primary Purpose
End-Stage Renal Disease, Hemodialysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TASCCI
Technology Delivered Health Education Intervention
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- undergoing thrice-weekly maintenance hemodialysis for > 3 months
- English speaking
- able to provide informed consent
- no evidence of thought disorder, delusions or active suicidal ideation
Exclusion Criteria:
- thought disorder, delusions or active suicidal ideation
- active substance abuse
- too ill or cognitively impaired to participate based on clinicians' judgment
- anticipated life expectancy of less than 1 year
- unable or unwilling to adhere to study protocol
- participating in another clinical trial or taking an investigational drug
- scheduled for living donor kidney transplant within next 6 months
- relocating to another dialysis unit within 6 months
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
TASCCI
Technology Delivered Health Education
Arm Description
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.
Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis.
Outcomes
Primary Outcome Measures
Change in depression from baseline to 12 weeks
Depressive symptoms will be measured using the Beck Depression Inventory-II
Change in pain from baseline to 12 weeks
Pain symptoms will be measured using the Brief Pain Inventory
Change in fatigue from baseline to 12 weeks
Fatigue symptoms will be measured using the FACIT-F
Secondary Outcome Measures
Change in adherence to medications
Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine
Change in adherence to fluid restriction
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
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.
Full Information
NCT ID
NCT03440853
First Posted
January 31, 2018
Last Updated
July 7, 2022
Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT03440853
Brief Title
Technology Assisted Stepped Collaborative Care Intervention
Acronym
TASCCI
Official Title
Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Patient reported outcomes will be administered centrally by blinded interviewers using computer-assisted telephone interviewing (CATI).
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TASCCI
Arm Type
Experimental
Arm Description
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.
Arm Title
Technology Delivered Health Education
Arm Type
Other
Arm Description
Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis.
Intervention Type
Behavioral
Intervention Name(s)
TASCCI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Technology Delivered Health Education Intervention
Intervention Description
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 Measure Information:
Title
Change in depression from baseline to 12 weeks
Description
Depressive symptoms will be measured using the Beck Depression Inventory-II
Time Frame
Baseline and Post 12 week intervention
Title
Change in pain from baseline to 12 weeks
Description
Pain symptoms will be measured using the Brief Pain Inventory
Time Frame
Baseline and Post 12 week intervention
Title
Change in fatigue from baseline to 12 weeks
Description
Fatigue symptoms will be measured using the FACIT-F
Time Frame
Baseline and Post 12 week intervention
Secondary Outcome Measure Information:
Title
Change in adherence to medications
Description
Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine
Time Frame
Baseline, 3 month, 6 month, 12 month
Title
Change in adherence to fluid restriction
Description
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
Time Frame
Baseline, 3 month, 6 month, 12 month
Title
Change in adherence to hemodialysis treatments
Description
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.
Time Frame
Baseline and Post 12 week intervention
Other Pre-specified Outcome Measures:
Title
To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-α) on biomarkers of inflammation
Description
Effect of intervention on biomarkers of inflammation be measured by improvements in inflammatory cytokines.
Time Frame
Baseline and Post 12 week intervention, 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
undergoing thrice-weekly maintenance hemodialysis for > 3 months
English speaking
able to provide informed consent
no evidence of thought disorder, delusions or active suicidal ideation
Exclusion Criteria:
thought disorder, delusions or active suicidal ideation
active substance abuse
too ill or cognitively impaired to participate based on clinicians' judgment
anticipated life expectancy of less than 1 year
unable or unwilling to adhere to study protocol
participating in another clinical trial or taking an investigational drug
scheduled for living donor kidney transplant within next 6 months
relocating to another dialysis unit within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Jhamb, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Technology Assisted Stepped Collaborative Care Intervention
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