University of Maryland


Grant Number: 1U01AR057967-01
Project Title: Development and Validation of a Self–Efficacy Item Bank
PI Name, Title and Contact Information: Lisa Shulman, MD, Principal Investigator Professor of Neurology, The Eugenia Brin Professor in Parkinson's Disease and Movement Disorders, The Rosalyn Newman Distinguished Scholar in Parkinson's Disease, University of Maryland School of Medicine
Other Key Personnel: Craig Velozo, PhD, OTR/L, Co-Investigator
Ann Gruber-Baldini, PhD, Co-Investigator
Web Site:  

Lisa Shulman's video presentation

NIH PROMIS 2011 - Advancing PRO Science in Clinical Research and Patient Care

Abstract:

In keeping with the purpose of the PROMIS initiative, this proposal describes a study to establish the new domain of self–efficacy that is part of the existing PROMIS Domain Framework. Self-efficacy is defined as an individual’s perception of their ability to successfully perform certain tasks or behaviors, or more specifically, as the belief that one can carry out a behavior to achieve a desired goal related to one’s health. Our study will focus upon self–efficacy for self-management of chronic medical conditions. We will employ samples from five chronic neurologic disorders in order to validate this domain. The significance of self–efficacy is based on two main features:

  1. self–efficacy is a pivotal mediator of human behavior and
  2. self-efficacy has been shown to be modifiable by interventions that foster self-management skills. The translation of advances in science and clinical practice depends upon modifications of human behavior, such as adherence to new medical regimens or changes of lifestyle. Successful adjustment and good outcomes in chronic disorders depend upon the ability to adopt and master new behaviors. From this perspective, improved understanding of the role of self–efficacy in the self–management of chronic medical conditions plays a key role in improving quality of care.

A multi–step process will be employed to develop the item pool, with contributions from experts in the field of self–efficacy, clinicians, and patients. We will target self–efficacy for self-management of chronic conditions, including diverse subdomains (e.g. managing medications, managing daily activities, performance of exercise and managing symptoms). Validation studies of the self–efficacy item pool will be conducted in five chronic neurologic disorders: epilepsy, multiple sclerosis, Parkinson’s disease, peripheral neuropathy, and stroke. We will investigate the effects of diverse features of these disorders on self–efficacy. Based on patient–reported data, we will assess the magnitude of a clinically important difference of the new self–efficacy measures. We will accomplish these goals by pursuing three specific aims:

AIM 1. To develop an item pool for assessing self–efficacy for self-management of chronic conditions

  • a) Obtain expert consensus on the subdomains of self–efficacy
  • b) Develop an item pool for the selected subdomains of self–efficacy
  • c) Perform qualitative validation of the item pool prior to field testing

AIM 2: To validate an item bank of self–efficacy in five chronic neurologic disorders

  • a) Verify the dimensional structure of the self–efficacy domain.
  • b) Determine the psychometric properties of the self–efficacy subdomains
  • c) Determine item measure stability across selected demographics and neurologic disorders

AIM 3: To investigate the derived measures of self–efficacy in chronic neurologic disorders

  • a) Assess differences in self–efficacy across five neurologic disorders
    • Hypothesis 3a: Self–efficacy for self–management will be most affected by MS and epilepsy and least affected in PD and peripheral neuropathy, due to differences in disease course and symptom profile.
  • b) Assess the effects of the symptom profiles of five neurologic disorders on the self-efficacy subdomains within and across the disorders
    • Hypothesis 3b: The time course of symptoms (stable vs. episodic vs. progressive) and level of depression will have a greater effect on self-efficacy than the level of impairment or disability.
  • c) Determine the magnitude of a clinically important difference for the self-efficacy subdomains.
    • Hypothesis 3c: The derived self-efficacy measures will be sufficiently sensitive to capture change that can be linked to clinically meaningful outcomes.

This study is unique in that it will develop a new domain and item bank for PROMIS and will simultaneously validate this domain in five chronic neurologic disorders. Self–efficacy is poorly understood by the clinical research community; this PROMIS item bank will foster more research in self-efficacy for self-management of chronic conditions. The ultimate goal of these studies is to provide information that will aid in the development of interventions to improve self-efficacy, promote self-management and reduce and delay disability.

Patient Populations:

The sample will be comprised of patients diagnosed with five chronic neurologic disorders: epilepsy, multiple sclerosis, Parkinson’s disease, peripheral neuropathy, and stroke.

Inclusion/Exclusion criteria: Eligibility is based on age > 18 years, Montreal Cognitive Assessment (MOCA) >20, English language sufficient for informed consent and questionnaire completion (NIHSS aphasia score ≥2), and absence of severe or unstable medical or psychiatric co-morbidities.

Sample size: A minimum of 200 subjects per diagnostic group for a total sample of at least 1000 subjects. Oversampling is anticipated in epilepsy, Parkinson’s disease and peripheral neuropathy.

For questions concerning University of Maryland’s role in the PROMIS network, please contact either Lisa Shulman, MD, by e-mail at lshulman@som.umaryland.edu or Cherika Greene, Administrative Assistant to Dr. Shulman, by e-mail at chgreene@som.umaryland.edu. For more information about the PROMIS network, go to http://www.nihpromis.org.