title: Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.
abstract: OBJECTIVE
  To compare treatment fidelity among treatment arms in the Telephone Assessment and Skill-Building Kit study for stroke caregivers (TASK II) with respect to: 1) protocol adherence; 2) intervention dosage and 3) nurse intervener perspectives.
  
  
  METHODS
  A randomized controlled clinical trial design.
  
  
  METHODS
  Urban, community, midwestern United States.
  
  
  METHODS
  A total of 254 stroke caregivers (mean ±SD age, 54.4 ±11.8 years), 55 (22.0%) males and 199 (78.4%) females) randomized to the TASK II intervention (n=123) or an Information, Support, and Referral comparison group (n=131).
  
  
  METHODS
  TASK II participants received the TASK II Resource Guide; Information, Support, and Referral participants received a standard caregiver brochure. At approximately 8 weeks after discharge, both groups received 8 weekly calls from a nurse, with a booster call 4 weeks later.
  
  
  METHODS
  Protocol adherence was evaluated with the TASK II Checklist for Monitoring Adherence. Intervention dosage was measured by the number of minutes caregivers spent reading materials and talking with the nurse. Nurse intervener perspectives were obtained through focus groups.
  
  
  RESULTS
  Protocol adherence was 80% for the TASK II and 92% for the Information, Support, and Referral. As expected, intervention dosage differed between TASK II and Information, Support, and Referral with respect to caregiver time spent reading materials (t=-6.49; P<.001) and talking with the nurse (t=-7.38; P<.001). Focus groups with nurses yielded further evidence for treatment fidelity and recommendations for future trials.
  
  
  CONCLUSIONS
  These findings substantiate treatment fidelity in both study arms of the TASK II stroke caregiver intervention trial (NIH R01NR010388; ClinicalTrials.govNCT01275495).
authors.affiliation: Indiana University School of Nursing, Indiana University, USA smclenno@iu.edu.
authors.forename: Susan M
authors.initials: SM
authors.lastname: McLennon
authors.affiliation: Indiana University School of Nursing, Indiana University, USA.
authors.forename: Rebecca D
authors.initials: RD
authors.lastname: Hancock
authors.affiliation: Indiana University School of Nursing, Indiana University, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Redelman
authors.affiliation: Indiana University School of Nursing, Indiana University, USA.
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Scarton
authors.affiliation: Indiana University School of Nursing, Indiana University, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Riley
authors.affiliation: Indiana University School of Nursing, Indiana University, USA.
authors.forename: Bobbie
authors.initials: B
authors.lastname: Sweeney
authors.affiliation: University of Delaware College of Health Sciences, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Habermann
authors.affiliation: Indiana University School of Nursing, Indiana University, USA.
authors.forename: Nenette M
authors.initials: NM
authors.lastname: Jessup
authors.affiliation: Indiana University School of Nursing, Indiana University, USA.
authors.forename: Tamilyn
authors.initials: T
authors.lastname: Bakas
mesh_terms: D001291:Attitude of Health Personnel; D017028:Caregivers / Q000193:education* / Q000523:psychology; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008875:Middle Aged; D015146:Midwestern United States; D024802:Nurse's Role; D011368:Professional-Family Relations; D012944:Social Support; D020521:Stroke / Q000628:therapy*
keywords: Family caregivers; behavioral research; stroke; telephone assessment