Skip to content

Family Meeting Study for End Stage Renal Disease

Family Consultation for High-Risk Inpatients With End Stage Renal Disease: A Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02504021
Enrollment
120
Registered
2015-07-21
Start date
2015-07-31
Completion date
2016-10-31
Last updated
2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease

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.

Detailed description

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.

Interventions

BEHAVIORALFamily Consultation

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

Sponsors

Henry Ford Health System
CollaboratorOTHER
Mark A. Lumley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early Hospital Readmissions - 1 Month1 MonthWere patients readmitted to the hospital within 1 month of their initial discharge?

Secondary

MeasureTime frameDescription
Change in Medication AdherenceBaseline and 1-month follow-upAdherence to medication regimen. Items modified from Immunosuppressant Therapy Adherence Scale.
Change in DepressionBaseline and 1-month follow-upAssessed using Patient Health Questionnaire 8
Change in Instrumental Social SupportBaseline and 1-month follow-upAmount of involvement of support people in terms of disease management. Items modified from the Diabetes Social Support Questionnaire-Family.
Change in Biological Measures of HealthBaseline, 1, and 3 monthsBased on chart review, investigators will assess BUN, creatinine, substance use (tox screen), phosphorous, comorbidities, mortality
Hospital Readmissions - 3 Months3 MonthsWere patients readmitted to the hospital within 3 months of their initial discharge?
Change in AnxietyBaseline and 1-month follow-upAssessed using Generalized Anxiety Disorder Questionnaire-7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026