Family Meeting Study for End Stage Renal Disease

NCT02504021 | Completed

• 1 other identifier: HFHS IRB 9714
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial for patients with end stage renal disease in which a family consultation condition is compared against a treatment as usual control condition on the hospital readmissions after 1 month as the primary outcome variable.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Early Hospital Readmissions - 1 Month

  Were patients readmitted to the hospital within 1 month of their initial discharge?

  1 Month

Secondary Outcomes (6)

• Change in Instrumental Social Support

  Baseline and 1-month follow-up

• Change in Medication Adherence

  Baseline and 1-month follow-up

• Change in Depression

  Baseline and 1-month follow-up

• Change in Anxiety

  Baseline and 1-month follow-up

• Change in Biological Measures of Health

  Baseline, 1, and 3 months

Study Arms (2)

Family Consultation Condition

EXPERIMENTAL

The family consultation will be one, 1-hour session conducted by trained, master's level therapists. The goals of the meetings are: a) Review patient and family understanding of events that caused the hospital admission; b) increase family awareness of the level of cognitive impairment that the patient is experiencing; c) discuss ways the family can get involved and help the patient with their medication and dialysis adherence; d) use motivational interviewing techniques as needed. This will be provided in addition to the usual care that inpatients receive in this unit.

Behavioral: Family Consultation

Treatment as Usual Control Condition

NO INTERVENTION

Standard of care for the nephrology unit.

Interventions

Family Consultation BEHAVIORAL

This intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques.

Family Consultation Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized in inpatient Nephrology Unit at Henry Ford Hospital
• Has end-stage renal disease
• Willing and able to contact support person / family member about participating in the study

You may not qualify if:

• Persistent Delirium
• Non-English speaking

Sponsors & Collaborators

• Mark A. Lumley: lead
• Henry Ford Health System: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark W Ketterer, Ph.D.

  Henry Ford Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 21, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

US (1)