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Family Meeting Study for End Stage Renal Disease

NCT ID: NCT02504021

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Patients hospitalized at Henry For Hospital who have end stage renal disease will complete baseline questionnaires and be randomized into the experimental or control condition. Patients randomized into the experimental condition will have a single family consultation session before the patient is discharged. A trained, master's level therapist will conduct the family consultation, which will use education, motivational interviewing, and other techniques to help the family engage and support the patient's health needs. Patients in both the experimental and control conditions will complete follow up questionnaires 1 month after discharge. Investigators will conduct chart reviews of outcome data, including readmissions, at 1, 3, and 6 months post-discharge.

Conditions

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End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Family Consultation Condition

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.

Group Type EXPERIMENTAL

Family Consultation

Intervention Type BEHAVIORAL

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

Treatment as Usual Control Condition

Standard of care for the nephrology unit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Family Consultation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Persistent Delirium
* Non-English speaking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role collaborator

Mark A. Lumley

OTHER

Sponsor Role lead

Responsible Party

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Mark A. Lumley

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark W Ketterer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health Systems

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HFHS IRB 9714

Identifier Type: -

Identifier Source: org_study_id