Skill-building through Task-Oriented Motor Practice (STOMP) intervention for activities of daily living: study protocol for a randomized, single blinded clinical trial.

BACKGROUND: Progressive disability in activities of daily living (ADL) is inevitable for people with Alzheimer's disease and related dementias (ADRD). Attempts to slow or prevent ADL disability have been unsuccessful despite making progress in behavioral training methods. Missing from this research is an emphasis on how we maximize a patient's engagement during training and the rigorous examination of implementation protocols (dosing and training methods) which may advantage learning in people with ADRD. Our team addressed this gap with the development of the STOMP (Skill-building through Task-Oriented Motor Practice) intervention which creates methods for obtaining ADL goals that support "personhood" and tests high-intensity protocols that appear to advantage learning and sustained learning over time. Through this study, we aim to evaluate differential outcomes by dose levels as well as assess the moderating effects of attention to task during training. METHODS/DESIGN: Randomized-controlled trial with 32 participants with dementia assigned to either the original, intensive STOMP protocol (3 hours/day, 5 days/week for 2 weeks) or a less-intensive STOMP protocol (1 hour/day, 2 days/week for 2 weeks) delivered by an occupational therapy assistant in the home. ADL training is delivered using motor learning theory techniques of blocked practice, continuous verbal praise, errorless learning and intense dosing schedules. Inclusion criteria: English speaking, adults 50-80 years old that live with a legally-authorized representative that can provide consent, who can follow a one-step command, have three ADL goals they want to address and can participate in an intense therapy protocol. Exclusions include diagnoses of Creutzfeldt-Jakob Dementia, delirium or receptive/global aphasia. Recruitment will occur through direct mailing, physician referral and media/support group presentations. Blinded occupational therapists will complete baseline, post-intervention and 3-month follow-up assessments in the home. Repeated measures ANOVA and graphs will be used to interpret and display results. DISCUSSION: Through this protocol, we will examine differential outcomes by dose for the STOMP ADL intervention. Our results will inform dosing parameters for future intervention studies for people with ADRD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02356055. ETHICAL APPROVAL: This study protocol was approved by the University of Oklahoma Health Sciences Center Institutional Review Board (#4648) and will be performed in accordance with the Declaration of Helsinki.

User-centered design and usability testing of an innovative health-related quality of life module.

OBJECTIVES: Various computerized health risk appraisals (HRAs) are available, but few of them assess health-related quality of life (HRQoL) in a goal-directed framework. This study describes the user-centered development and usability testing of an innovative HRQoL module that extends a validated HRA tool in primary care settings. METHODS: Systematic user-centered design, usability testing, and qualitative methods were used to develop the HRQoL module in primary care practices. Twenty two patients and 5 clinicians participated in two rounds of interactive technology think-out-loud sessions (TOLs) and semi-structured interviews (SSIs) to iteratively develop a four-step, computerized process that collects information on patient goals for meaningful life activities and current level of disability and presents a personalized and prioritized list of preventive recommendations linked to online resources. RESULTS: Analysis of TOLs and SSIs generated 5 categories and 11 sub-categories related to facilitators and barriers to usability and human-technology interaction. The categories included: Understanding the Purpose, Usability, Perceived Value, Literacy, and Participant Motivation. Some categories were inter-connected. The technology was continually and iteratively improved between sessions until saturation of positive feedback was achieved in 4 categories (addressing motivation will require more research). Usability of all screen units of the module was improved substantially. Clinician feedback emphasized the importance of the module's ability to translate the patient-centered HRQoL Report into actionable items for clinicians to facilitate shared decision-making. Complete integration of the HRQoL module into the existing HRA will require further development and testing. CONCLUSIONS: Systematic application of user-centered design and human factors principles in technology development and testing may significantly improve the usability and clinical value of health information systems. This more sophisticated approach helped us translate complex clinical concepts, goal-setting steps, and decision-support processes into an accepted and value-added technology.

Comparing Differences in ADL Outcomes for the STOMP Intervention for Dementia in the Natural Home Environment Versus a Clinic Environment.

BACKGROUND: Few studies have examined structured rehabilitation techniques for improving activities of daily living in people with mild-moderate dementia. We sought to examine the advantages to delivering the Skill-building through Task-Oriented Motor Practice (STOMP) intervention in the home environment (versus the clinic), hypothesizing that ADL improvement would be significantly better, time to meeting goals would be faster and fewer displays of behavior would be noted. METHODS: Compared results of two quasi-experimental studies of STOMP, one completed in the home, one completed previously in a clinic. Participants were English-speaking; community dwelling adults aged 50-90 diagnosed with mild-moderate dementia who could participate in an intensive rehabilitation program (5 days/week, 3 hours/day, for 2 weeks). Outcome measurements include examiner-observation of performance and proxy-report of performance and satisfaction with performance in patient-selected goals. RESULTS: No differences existed in the sociodemographic characteristics between the home and clinic groups where the groups were primarily white, married, had > high school education and had mild-moderate dementia. Results from the home group indicate that participants made significant improvement in ADL which was generally retained at the 90 day follow-up. These results were not significantly different than the clinic group. No significant advantages were noted for the home group in terms of time to meeting goals or exhibition of fewer behaviors. DISCUSSION: The STOMP intervention appeared to work equally as well in the home and in the clinic. Future studies should continue to examine the benefits of massed practice using high-dose regimens.