Trial Outcomes & Findings for HRQoL in the Low MELD Pre-tx Population (NCT NCT01573325)

Results Overview

Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

2-3 months

Results posted on

2014-02-28

Participant Flow

50 Subjects were recruited from NMH clinic and satellite clinics. Recruitement was from 03/29/12 to 06/19/12

Participant milestones

Participant milestones
Measure	Study Popoulation There was only one group as this was a descriptive prospective study. They all completed identical questionnaires including the Quality of Life Index, the Short-form Liver Disease Quality of Life tool, the Medical Outcomes Study Social Support Survey, the demographic tool and the Center for Epidemiological Studies Depression tool.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HRQoL in the Low MELD Pre-tx Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Popoulation n=50 Participants There was only one group as this was a descriptive prospective study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	56.26 years STANDARD_DEVIATION 10.774 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-3 months

Population: Entire study population was analyzed

Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.

Outcome measures

Outcome measures
Measure	Study Popoulation n=50 Participants There was only one group as this was a descriptive prospective study
Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.	20.19 scores on a scale Standard Deviation 5.98

SECONDARY outcome

Timeframe: 2-3 months

Population: Entire study population was analyzed

Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.

Outcome measures

Outcome measures
Measure	Study Popoulation n=50 Participants There was only one group as this was a descriptive prospective study
Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL	78 percentage of participants

Adverse Events

Study Popoulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rebecca Duke DNP, MSN, NP-BC Transplant Surgery Nurse Practitioner

Northwestern Memorial Hospital

Phone: 3126951686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place