Collaborative Care Intervention for Chronic Kidney Disease

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT02938351
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 57
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant; Depression; Pain	Behavioral: Collaborative care	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessionsPatient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessions
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Collaborative Care Intervention for Kidney Transplant Patients
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 7, 2019
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: collaborative care To test the efficacy of a collaborative care intervention with patients treated with dialysis to reduce depression, pain, fatigue, and improve quality of life

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.

Outcome Measures

Primary Outcome Measures

1. Depression Level [change from baseline at 3 month and 6 month]

   score on CES-D questionnaire

2. Perceived Stress level [change from baseline at 3 month and 6 month]

   score on PSS questionnaire

3. degree of Pain [change from baseline at 3 month and 6 month]

   score on the BPI questionnaire

Secondary Outcome Measures

1. Dyadic functioning [change from baseline at 3 month and 6 month]

   score on the Dyadic functioning questionnaire

2. level of physical activity (mild, moderate or high) [change from baseline at 3 month and 6 month]

   calculated score on the International Physical Activity quationnaire

3. sleep quality [change from baseline at 3 month and 6 month]

   score on the PSQI questionnaire

4. quality of life [change from baseline at 3 month and 6 month]

   score on the KDQOL questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: Jennifer Steel, PhD, University of Pittsburgh Physicians

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Steel, Associate Professor of Surgery, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02938351
• Other Study ID Numbers: PRO15110210
• First Posted: Oct 19, 2016
• Last Update Posted: May 4, 2021
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jennifer Steel, Associate Professor of Surgery, University of Pittsburgh: Collaborative care intervention; kidney transplant
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of May 4, 2021