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

NCT02435628 | Completed

• 1 other identifier: 2014P002755
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Age, Gender, Ethnicity, and Race of Patients with NF

  Baseline (pre-medical visit)

• Visual Analog Health Scale

  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

  Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.

Study Arms (1)

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

Interventions

Questionnaires OTHER

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.

Satisfaction Questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with neurofibromatosis 1, neurofibromatosis 2, or schwannomatosis

You may qualify if:

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

You may not qualify if:

• 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)
• Unable or unwilling to participate
• Unable or unwilling to complete psychological assessments online via the REDCap or Assessment Center systems.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neurofibromatoses

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 6, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

US (1)