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NCT Number: NCT02435628

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: Baseline (pre-medical visit)

    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.

  2. Functional, Communicative and Critical Health Literacy (FFFHL) scale

    Time frame: Baseline (pre-medical visit)

    Measures one's health literacy, the capacity of individuals to access, understand, and use health information to make informed and appropriate health-related decisions.

  3. Medical Interview Satisfaction Scale (MISS)

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

    Measures patient satisfaction with individual doctor-patient consultations.

  4. Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey

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

    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.

Other outcomes

  1. Age, Gender, Ethnicity, and Race of Patients with NF

    Time frame: Baseline (pre-medical visit)

    The questionnaire asks for the patient's age, gender, ethnicity, and race as part of the basic demographics.

  2. Visual Analog Health Scale

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

    Measures one's current health on a scale from 0 ("very poor") to 10 ("very good").

  3. Learning Disabilities of Patients with NF

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

    This question asks patients if they have ever been diagnosed with a learning disability.

  4. First Time at NF Clinic

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

    This question asks the patient if it's their first time at the MGH NF clinic.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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