End-stage Renal DiseaseNCT02504021
Family Meeting Study for End Stage Renal Disease
A study testing Family Consultation in people with End-stage Renal Disease, run by Mark A. Lumley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Family Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Persistent Delirium
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Consultation for High-Risk Inpatients With End Stage Renal Disease: A Randomized Trial
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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Being tested
- Family Consultation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family ConsultationBehavioural
This intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Consultation |
| Treatment as Usual Control Condition | No intervention | Standard of care for the nephrology unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Hospital Readmissions - 1 Month
Were patients readmitted to the hospital within 1 month of their initial discharge?
Measured: 1 Month
Secondary outcomes (6)
Change in Instrumental Social Support
Amount of involvement of support people in terms of disease management. Items modified from the Diabetes Social Support Questionnaire-Family.
Measured: Baseline and 1-month follow-up
Change in Medication Adherence
Adherence to medication regimen. Items modified from Immunosuppressant Therapy Adherence Scale.
Measured: Baseline and 1-month follow-up
Change in Depression
Assessed using Patient Health Questionnaire 8
Measured: Baseline and 1-month follow-up
Change in Anxiety
Assessed using Generalized Anxiety Disorder Questionnaire-7
Measured: Baseline and 1-month follow-up
Change in Biological Measures of Health
Based on chart review, investigators will assess BUN, creatinine, substance use (tox screen), phosphorous, comorbidities, mortality
Measured: Baseline, 1, and 3 months
Hospital Readmissions - 3 Months
Were patients readmitted to the hospital within 3 months of their initial discharge?
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark A. Lumley
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Health System
- Responsible party
- Sponsor-investigator, Mark A. Lumley, Wayne State University
- Investigators
- Mark W Ketterer, Ph.D., Principal investigator, Henry Ford Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504021
- Sponsor's protocol ID
- HFHS IRB 9714
- Status last verified
- Sep 2017
- First submitted
- 14 Jul 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Consultation for High-Risk Inpatients With End Stage Renal Disease: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02504021
- Acronym / sponsor ID
- HFHS IRB 9714
- Conditions
- End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mark A. LumleyUniversity, hospital or other
- Collaborators
- Henry Ford Health System
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Consultation Condition | Experimental | Behavioral: Family ConsultationThe 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. |
| Treatment as Usual Control Condition | No intervention | –Standard of care for the nephrology unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Persistent Delirium
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family ConsultationThis intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques. | Behavioural | Family Consultation Condition |
Primary outcome
Early Hospital Readmissions - 1 Month
Time frame: 1 Month
Were patients readmitted to the hospital within 1 month of their initial discharge?
6 secondary outcomes
Change in Instrumental Social Support
Time frame: Baseline and 1-month follow-up
Change in Medication Adherence
Time frame: Baseline and 1-month follow-up
Change in Depression
Time frame: Baseline and 1-month follow-up
Change in Anxiety
Time frame: Baseline and 1-month follow-up
Change in Biological Measures of Health
Time frame: Baseline, 1, and 3 months
Hospital Readmissions - 3 Months
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
Related trials for End-stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W Ketterer, Ph.D. principal investigator
Henry Ford Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Consultation in people with End-stage Renal Disease, run by Mark A. Lumley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Hospital Readmissions - 1 Month (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.