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Completed

NCT Number: NCT03440853

Technology Assisted Stepped Collaborative Care Intervention

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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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TASCCI

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 Intervention

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.

Primary outcomes

  1. Change in depression from baseline to 12 weeks

    Time frame: Baseline and Post 12 week intervention

    Depressive symptoms will be measured using the Beck Depression Inventory-II

  2. Change in pain from baseline to 12 weeks

    Time frame: Baseline and Post 12 week intervention

    Pain symptoms will be measured using the Brief Pain Inventory

  3. Change in fatigue from baseline to 12 weeks

    Time frame: Baseline and Post 12 week intervention

    Fatigue symptoms will be measured using the FACIT-F

Secondary outcomes

  1. Change in adherence to medications

    Time frame: Baseline, 3 month, 6 month, 12 month

    Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine

  2. Change in adherence to fluid restriction

    Time frame: Baseline, 3 month, 6 month, 12 month

    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

  3. Change in adherence to hemodialysis treatments

    Time frame: Baseline and Post 12 week intervention

    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.

Other outcomes

  1. To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-α) on biomarkers of inflammation

    Time frame: Baseline and Post 12 week intervention, 6 month

    Effect of intervention on biomarkers of inflammation be measured by improvements in inflammatory cytokines.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of New Mexico

Registry information

Official study title

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

Acronym: TASCCI

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2018
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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