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

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ClinicalTrials.gov Identifier: NCT02435628
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Neurofibromatosis Other: Questionnaires

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : February 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


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.




Primary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with neurofibromatosis 1, neurofibromatosis 2, or schwannomatosis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435628


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ana-Maria Vranceanu, PhD Massachusetts General Hospital

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Responsible Party: Ana-Maria Vranceanu, PhD, Clinical Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02435628     History of Changes
Other Study ID Numbers: 2014P002755
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Neurofibromatoses
Neurofibromatosis 1
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
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms