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. Author manuscript; available in PMC: 2015 May 1.
Published in final edited form as: Appl Nurs Res. 2014 Oct 2;28(2):156–162. doi: 10.1016/j.apnr.2014.09.006

Table 1.

Process evaluation plan and results.

Component of study Method of evaluation Results
Recruitment and retention

Recruitment
  • Number approached

  • Duration of recruitment

  • Ability to obtain and retain desired number of subjects

  • Compare completers to non-completers

  • Able to recruit 20 subjects of 172 approached

  • 6 months

  • Loss of 5 subjects during 12-week follow-up

  • Completers had significantly higher levels of total and moderate physical activity and walking

Recruitment methods
  • Onsite

  • Flyers

  • Previous research participants

  • # of participants recruited via each method

  • Assess barriers to each method of recruitment

  • Onsite (16); Flyers (0); Previous research (4)

  • No-show patients and high traffic in clinic impeded recruitment


Implementation

Fidelity

Initial counseling session
  • Session fully audiotaped

  • Essential elements covered according to interview guide

  • Adherence to principals of MI as assessed by independent auditor familiar with MI techniques

  • 100% audiotaped

  • All essential elements covered as planned

  • MI tapes reviewed (n = 4) during study period. Adherence to principles of MI was 40–50% in subject 4 and 5 and increased to 100% and 80% in subject 16 and 20.

Weekly phone calls delivered
  • % of weekly calls successfully made/step counts obtained

  • 168/180 calls with collected data (93% of calls successfully made/step data collected)

Phone call assessment of adverse events as part of data safety monitoring plan
  • % of participants who have adverse events assessed

  • % of participants who report an adverse event (include type of event)

  • % of participants hospitalized

  • Patients were assessed weekly for adverse events (except for missing phone contact: 7%)

  • No adverse events related to intervention occurred during study period.

  • 4 subjects required hospitalization during study: one for HF symptoms; one for a stroke; one for electrolyte imbalance; one for elective catheterization and post-catheterization arrhythmia.

Phone call assessment of concerns or barriers related to exercise
  • % of calls that include assessment of exercise concerns or barriers to exercise

  • 100% of calls with successful contact reviewed concerns/barriers. Subjects were able to identify symptoms and barriers which were discussed


Dose

Counseling Session
  • Duration of session (minutes)

  • Mean duration of initial session = 1 hour; mean interview time: 12.57 ± 4.84 minutes

Successful phone contact Phone call duration
  • Percentage of calls that result with contact with participant

  • Assess length of each call in minutes

  • 93% phone call contact successful

  • Approximate length of each call: 5 minutes

Phone call content
  • Notes taken during each call regarding content areas

  • Notes taken during each call: content focused on activity conducted in prior week; symptoms experienced; plan for following week to maintain or increase step count according to subjects’ willingness; symptom management

Adherence to daily diary
  • Step count

  • Corresponding Borg scale

  • Daily weight

  • Use of hand weights

  • Assess % of days each component is documented for 15 subjects (of 84 days total)

  • Step count recorded: 801/1260 = 64% of days

  • Borg scale: 628/1260 = 50% of days

  • Daily weight: 651/1260 = 52% of days

  • Hand weight use: 400/1260 = 32% of days


Context

Ability to conduct intervention at site during clinic hours
  • Qualitative assessment of site, staffing, logistics

  • Use of CTSI research unit was essential in collecting data since private area was need for data collection and long hallway was required for functional capacity data

  • Providers varied in their referral of potential subjects

  • The majority of subject data was collected on the day of visit. Some subjects chose to return to clinic for data collection


Reach

Reach Participation rate
  • Ability to recruit in target population

  • % of patients who agreed to participate

  • Collection of data regarding why subjects were excluded + age and gender collected

  • 20 low-income ethnic minority adults with HF recruited

  • Demonstrated ability to recruit in HF clinic

  • n = 172 approached; n = 152 excluded per criteria or declined to participate

  • Data collected on all patients approached but excluded; age and gender collected

Note. CTSI = Clinical and Translational Science Institute; HF = heart failure; MI = motivational interviewing.