Date Presented 4/7/2016
Feasibility and acceptability of an intensive stroke treatment was determined by whether recruitment goals were met, adherence to treatment protocol, responses to study satisfaction questionnaires, and analysis of pre and post Canadian Occupational Performance Measure satisfaction scores.
Primary Author and Speaker: Megan Doherty
Additional Authors and Speakers: Erin King, Mary Ellen Stoykov, Rachel Lux
PURPOSE: To examine the feasibility and acceptability of an upper-limb intervention study for older adults.
RATIONALE: Researchers often experience difficulty with recruitment in randomized controlled trials (RCTs) as a result of overestimating the eligibility of and enrollment of potential participants; lack of transportation; scheduling difficulties; or medical complications. Due to these potential adversities, we are determining recruitment feasibility, adherence, and acceptability of an upper-limb intervention by older adults who have chronic upper-limb hemiparesis, the most common poststroke disability. This study examines bilateral motor priming (BMP), which is continuous, bilateral, symmetrical wrist flexion and extension used to prime the brain before an occupation-based task-specific training (TST) protocol. The daily schedule includes 2 hr of intervention; the test group will have a combination of BMP and TST, and the active comparator group will have a combination of health care education (HCE) and the same occupation-based TST.
DESIGN: This is a single-blind two-group intervention study using stratified randomization for group assignment (BMP or HCE). Groups are stratified by their level of function, which is determined by the participant’s initial score on the Fugl–Meyer Test of Upper Extremity Function (FMUE).
PARTICIPANTS: The target sample size is 16 individuals who are age 55 yr or older and a minimum of 6 mo poststroke. Participants must score between a 22 and 38 on the FMUE and cannot have contraindications to transcranial magnetic stimulation.
METHOD: Feasibility is determined by the number of participants who enroll in the study, and retention is determined by how many participants complete the study. Acceptability of the intervention is assessed by a feedback questionnaire (close-ended questions) and changes in Canadian Occupational Performance Measure (COPM) satisfaction scores. A variety of recruitment methods were employed and tracked monthly to determine the most generative sources.
ANALYSIS: Methods of recruitment will be examined using histograms and descriptive statistics. Adherence is determined by attendance and repetitions completed during intervention. Acceptance will be determined through analysis of feedback questionnaires. COPM pre and post satisfaction scores will be analyzed using a one-way repeated-measures analysis of variance.
RESULTS: Ninety-three percent of the recruitment goal has been met, with a majority of referrals obtained from colleagues outside the institution. There was a recruitment lag during winter months, requiring an extension of the study timeline. Fifty-six participants have been screened and 14 enrolled. Twenty-six of the 33 excluded participants did not meet inclusion criteria; 3 declined to participate; and 4 were excluded for medical, transportation, or scheduling reasons. Only 1 of the enrolled participants had difficulty with adherence and was also lost to follow-up. Preliminary evaluation of feedback forms and an overall increase in COPM satisfaction scores indicate the intervention was well received by older adults.
DISCUSSION: Recruitment is one of the major obstacles to randomized clinical trials. The major obstacle to our recruitment was severe weather conditions in winter months. Preliminary analysis indicates that it is feasible to recruit and retain older adults for an intense upper-extremity intervention study.
IMPACT STATEMENT: Determining efficient participant recruitment methods are essential to the success of randomized clinical trials. Additionally, adherence and acceptability of time-intensive, physically demanding treatment models are critical to promoting quality evidence-based practice in stroke-related disability.
