Technology Assisted Stepped Collaborative Care Intervention (TASCCI)

University of Pittsburgh

Status: Completed

Conditions: End-Stage Renal Disease; Hemodialysis

Treatments: Behavioral: TASCCI; Other: Technology Delivered Health Education Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03440853

PRO17070630

1R01DK114085-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

TASCCI

Experimental group

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.

Treatment:

Behavioral: TASCCI

Technology Delivered Health Education

Other group

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.

Treatment:

Other: Technology Delivered Health Education Intervention