Collaborative Care Intervention for Chronic Kidney Disease

Depression Clinical Trial

Official title:

Collaborative Care Intervention for Kidney Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938351
• Other study ID #: PRO15110210
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2021
• Est. primary completion date: December 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Kidney Transplant
• Pain

Intervention

Behavioral:
• Collaborative care
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Level	score on CES-D questionnaire	change from baseline at 3 month and 6 month
Primary	Perceived Stress level	score on PSS questionnaire	change from baseline at 3 month and 6 month
Primary	degree of Pain	score on the BPI questionnaire	change from baseline at 3 month and 6 month
Secondary	Dyadic functioning	score on the Dyadic functioning questionnaire	change from baseline at 3 month and 6 month
Secondary	level of physical activity (mild, moderate or high)	calculated score on the International Physical Activity quationnaire	change from baseline at 3 month and 6 month
Secondary	sleep quality	score on the PSQI questionnaire	change from baseline at 3 month and 6 month
Secondary	quality of life	score on the KDQOL questionnaire	change from baseline at 3 month and 6 month