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NCT Number: NCT02504021

Family Meeting Study for End Stage Renal Disease

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Consultation

Behavioral

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

Primary outcomes

  1. Early Hospital Readmissions - 1 Month

    Time frame: 1 Month

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

Secondary outcomes

  1. Change in Instrumental Social Support

    Time frame: Baseline and 1-month follow-up

    Amount of involvement of support people in terms of disease management. Items modified from the Diabetes Social Support Questionnaire-Family.

  2. Change in Medication Adherence

    Time frame: Baseline and 1-month follow-up

    Adherence to medication regimen. Items modified from Immunosuppressant Therapy Adherence Scale.

  3. Change in Depression

    Time frame: Baseline and 1-month follow-up

    Assessed using Patient Health Questionnaire 8

  4. Change in Anxiety

    Time frame: Baseline and 1-month follow-up

    Assessed using Generalized Anxiety Disorder Questionnaire-7

  5. Change in Biological Measures of Health

    Time frame: Baseline, 1, and 3 months

    Based on chart review, investigators will assess BUN, creatinine, substance use (tox screen), phosphorous, comorbidities, mortality

  6. Hospital Readmissions - 3 Months

    Time frame: 3 Months

    Were patients readmitted to the hospital within 3 months of their initial discharge?

Sponsors and collaborators

Lead sponsor

Mark A. Lumley

Other

Collaborators

  • Henry Ford Health System

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2015
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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