Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With Medical Visits in Adults With NF

Neurofibromatosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435628
• Other study ID #: 2014P002755
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: April 2, 2017
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis

Intervention

Other:
• Questionnaires
All subjects will complete baseline psychological assessments prior to their medical visit. Upon completion of their routine medical visit, subjects will complete a post-test assessment measuring their satisfaction with the visit.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age, Gender, Ethnicity, and Race of Patients with NF	The questionnaire asks for the patient's age, gender, ethnicity, and race as part of the basic demographics.	Baseline (pre-medical visit)
Other	Visual Analog Health Scale	Measures one's current health on a scale from 0 ("very poor") to 10 ("very good").	Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Other	Learning Disabilities of Patients with NF	This question asks patients if they have ever been diagnosed with a learning disability.	Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Other	First Time at NF Clinic	This question asks the patient if it's their first time at the MGH NF clinic.	Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Primary	Patient Reported Outcomes Measurement Information System (PROMIS)	A battery of measures assessing: depression, anxiety, anger, fatigue, pain behavior and interference, physical function, satisfaction with discretionary social activities, satisfaction with social roles, and health literacy.	Baseline (pre-medical visit)
Primary	Functional, Communicative and Critical Health Literacy (FFFHL) scale	Measures one's health literacy, the capacity of individuals to access, understand, and use health information to make informed and appropriate health-related decisions.	Baseline (pre-medical visit)
Primary	Medical Interview Satisfaction Scale (MISS)	Measures patient satisfaction with individual doctor-patient consultations.	Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Primary	Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey	Asks patients to report on and evaluate their experiences with health care. This survey covers topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services.	Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.