Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 years or older;
undergoing thrice-weekly maintenance hemodialysis (HD) for > 3 months;
English or Spanish speaking;
able to provide informed consent
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Technology Assisted Stepped Collaborative Care
BehavioralThe TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.
Usual Care Arm
Other interventionParticipants in the Usual Care Arm will continue with their usual care.
Treatment groups
424 Participants
are divided into 2 treatment groupsGroup A: Technology Assisted Stepped Collaborative Care GroupActive comparator 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome)
Change in fatigue is a primary outcome. The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) will be used to measure fatigue. Scores range from 0-52 with lower scores indicating greater fatigue.
Time frame
6 months2
TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome)
Change in pain intensity score is also a primary outcome measure. The Brief Pain Inventory (BPI) will be used to measure pain intensity. The BPI uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.
Time frame
6 months3
TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome)
Change in depression severity score is also a primary outcome measure. The Beck Depression Inventory-II will be used to measure the depression severity score. Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.
Time frame
6 monthsSecondary outcomes
1
Fatigue
Change in fatigue measured by The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F). Scores range from 0-52 with lower scores indicating greater fatigue.
Time frame
3 and 12 months2
Pain Intensity
Change in pain intensity measured by Brief Pain Inventory (BPI), which uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.
Time frame
3 and 12 months3
Depression
Change in depression severity score using The Beck Depression Inventory-II (BDI-II). Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.
Time frame
3 and 12 months4
Pain interference
Brief Pain Inventory will be used to measure interference due to pain. Change in pain intensity measured by Brief Pain Inventory (BPI), which uses a scale of 0 to 10. Higher scores indicate worse pain interference.
Time frame
3, 6 and 12 monthsOther outcomes
1
Fatigue Assessment Scale
The Fatigue Assessment Scale (FAS) is scored by summing up the responses to each of its 10 items, where each item is rated on a 5-point Likert scale from "never" (1) to "always" (5), resulting in a total score ranging from 10 (minimal fatigue) to 50 (extreme fatigue) ; higher scores indicate greater fatigue severity.
Time frame
Every 4 weeks during 12 week intervention2
PROMIS Anxiety SF 8A
The PROMIS Anxiety SF 8A is scored by summing up the responses to each of the 8 questions, where each question is rated on a 5-point scale (1=never to 5=always), resulting in a raw score; this raw score is then converted into a T-score using a reference table to provide a standardized measure of anxiety severity, with a mean T-score of 50 and a standard deviation of 10 across the general population.
Time frame
Every 4 weeks during 12 week intervention3
PROMIS Depression SF 8A
The PROMIS Depression SF 8A is scored by summing up the responses to each of the 8 questions, where each question is rated on a 5-point scale from 1 ("Never") to 5 ("Always"), resulting in a raw score; this raw score is then converted into a T-score using a provided table to interpret the severity of depression, with higher T-scores indicating greater depression severity.
Time frame
Every 4 weeks during 12 week intervention4
Visual Analog Scale (VAS) for Pain
A Visual Analog Scale (VAS) for pain is a simple pain measurement tool where a patient marks a point on a 10cm line to indicate the intensity of their pain, with one end representing "no pain" and the other end representing "worst pain imaginable"; the score is determined by measuring the distance from the "no pain" end to the mark made by the patient, usually in centimeters, providing a numerical value representing their pain level
Time frame
Every 4 weeks during 12 week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of New Mexico
Collaborator
Source ClinicalTrials.gov