Technology Assisted Stepped Collaborative Care Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients

Conditions
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Hemodialysis, End-Stage Renal Disease

Intervention / Treatment
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* Behavioral: TASCCI
* Other: Technology Delivered Health Education Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TASCCI<br>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<br>* 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.<br>|
| Other: Technology Delivered Health Education<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression from baseline to 12 weeks | Depressive symptoms will be measured using the Beck Depression Inventory-II | Baseline and Post 12 week intervention | 
| Change in pain from baseline to 12 weeks | Pain symptoms will be measured using the Brief Pain Inventory | Baseline and Post 12 week intervention | 
| Change in fatigue from baseline to 12 weeks | Fatigue symptoms will be measured using the FACIT-F | Baseline and Post 12 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adherence to medications | Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine | Baseline, 3 month, 6 month, 12 month | 
| 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 | Baseline, 3 month, 6 month, 12 month | 
| 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. | Baseline and Post 12 week intervention |