Clinical trial NCT02435628: Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With Medical Visits in Adults With NF
Official title: Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With Medical Visits in Adults With Neurofibromatosis 1, Neurofibromatosis 2, and Schwannomatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurofibromatosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with neurofibromatosis 1, neurofibromatosis 2, or schwannomatosis

Brief summary: This is a prospective study through the NF clinic at Massachusetts General Hospital that will examine the relationship between psychosocial factors, health literacy, and satisfaction with the medical visit in adults with NF1, NF2, and Schwannomatosis. A total of 89 participants will be enrolled in the study.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Can read and speak English at or above the 6th grade level
3. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis

Exclusion Criteria:

1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
2. Unable or unwilling to participate
3. Unable or unwilling to complete psychological assessments online via the REDCap or Assessment Center systems.

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline (pre-medical visit)
measure: Functional, Communicative and Critical Health Literacy (FFFHL) scale
timeFrame: Baseline (pre-medical visit)
measure: Medical Interview Satisfaction Scale (MISS)
timeFrame: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey
timeFrame: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Secondary outcomes:
Other outcomes:
measure: Age, Gender, Ethnicity, and Race of Patients with NF
timeFrame: Baseline (pre-medical visit)
measure: Visual Analog Health Scale
timeFrame: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
measure: Learning Disabilities of Patients with NF
timeFrame: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
measure: First Time at NF Clinic
timeFrame: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: