Technology Assisted Stepped Collaborative Care Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2022-06-30

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.

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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.

Conditions

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End-Stage Renal Disease Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Patient reported outcomes will be administered centrally by blinded interviewers using computer-assisted telephone interviewing (CATI).

Study Groups

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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.

Group Type EXPERIMENTAL

TASCCI

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Technology Delivered Health Education Intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No