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Completed

NCT Number: NCT02938351

Collaborative Care Intervention for Chronic Kidney Disease

The aims of the present study will be to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

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Key information

Conditions

Kidney Transplant Behavior Behavioral Symptoms Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

Symptom management is critical to maintain quality of life in those with life limiting conditions. Stepped collaborative care interventions have been widely employed in the primary care setting for the treatment of depression and more recently have been utilized to treat other symptoms (e.g., pain) in a variety of settings. A recent meta-analyses concluded that collaborative care interventions were superior to usual care and are more cost-effective than face to face and pharmacological treatment for depression. Collaborative care interventions have begun to be extended to other settings but have not been tested in patients who are being treated with dialysis. The aims of the present study were to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 18 or older Currently receiving dialysis at UPMC dialysis facility for chronic kidney disease Fluent in English

Exclusion criteria

Under the age of 18 years or over 90 years Not fluent in English

Treatment and study plan

collaborative care

Behavioral

Therapist will use iPad (Vidyo) once a week during dialysis for approximately one hour. The therapist will teach the patient cognitive-behavioral strategies to manage their mood and pain. The PI is a clinical psychologist and will provide supervision to the therapist providing the intervention. The sessions for depression will include (1) intake, (2) review of the rational for using CBT to treat depression and/or pain, (3) identifying thought patterns, (4) changing thought patterns, (5) relaxation techniques, (6) rest-activity pacing, and (7) coping strategies. Homework to practice these techniques will be provided after each session.

Primary outcomes

  1. Depression Level

    Time frame: change from baseline at 3 month and 6 month

    score on CES-D questionnaire

  2. Perceived Stress level

    Time frame: change from baseline at 3 month and 6 month

    score on PSS questionnaire

  3. degree of Pain

    Time frame: change from baseline at 3 month and 6 month

    score on the BPI questionnaire

Secondary outcomes

  1. Dyadic functioning

    Time frame: change from baseline at 3 month and 6 month

    score on the Dyadic functioning questionnaire

  2. level of physical activity (mild, moderate or high)

    Time frame: change from baseline at 3 month and 6 month

    calculated score on the International Physical Activity quationnaire

  3. sleep quality

    Time frame: change from baseline at 3 month and 6 month

    score on the PSQI questionnaire

  4. quality of life

    Time frame: change from baseline at 3 month and 6 month

    score on the KDQOL questionnaire

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Collaborative Care Intervention for Kidney Transplant Patients

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Oct 19, 2016
Registry last updated
Dec 13, 2024

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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