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

Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With Medical Visits in Adults With Neurofibromatosis 1, Neurofibromatosis 2, and Schwannomatosis

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.

Study Overview

• Status: Completed
• Conditions: Neurofibromatosis
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with neurofibromatosis 1, neurofibromatosis 2, or schwannomatosis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Satisfaction Questionnaires; After enrollment, subjects will be given baseline measures to assess demographics, psychosocial factors, and health literacy. This assessment will occur online via Computerized Assessment Center. Participants will complete the PROMIS 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. Participants will also complete the FFFHL scale. Upon completion of the baseline assessments, the participant will meet with their doctor at the NF clinic for a routine appointment. Post-treatment assessments will be administered immediately after completion of the medical visit. This assessment will evaluate the participant's satisfaction with the appointment in the NF clinic using the MISS and CAHPS surveys. This will be done online via REDCap.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.
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.
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.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 2, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
• Other Study ID Numbers: 2014P002755