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. 2020 Nov 3;9(11):e19111. doi: 10.2196/19111

Table 4.

For exploratory aim 1, the primary outcomes include primary outcomes for specific aim 1 and treatment fidelity. For exploratory aim 2, the primary outcomes include primary outcomes for specific aim 1 and specific aim 2.

Title and description Time collected

Pre During Week 8 Week 12
Feasibility aim

Recruitment


Rate of recruitment (participants enrolled) per year Xa X X X



Number of participants screened per month X X X X



Number of participants enrolled per month X X X X



Number of participants lost to follow-up per month X X X X



Rate of retention per year X X X X

Treatment fidelity


Adequate knowledge of education program at 8-week follow-up X b X



Rating of audio recording by external reviewers for confidence of participant group allocation on 0-5 scale X



Time participants spent in treatment sessions X



Time participants spent doing education homework between sessions X



Adequate blinding of participants to bias of research team
  • “At the beginning of the study, you were randomized to receive either Education A or Education B. We believe Education A is more helpful for recovery from Achilles tendinopathy than Education B. Which Education do you think that you received?” (A, B, I don’t know)

X



Duration of each exercise phase X



Highest loading level attained at each exercise phase X



Therapeutic alliance
  • “What I was doing in physical therapy gave me new ways of looking at my problem.”

  • “I was confident my physical therapist’s ability to help me.”

  • “My PA and I were working towards mutually agreed upon goals.” (7-point scale from Never to Always)

X



Adherence to exercise program
X


Outcome capture rate


Percentage of missing data per outcome X X X X



Reasons for missing data X X X X

AEsc


Frequency and type of AEs X X X X
Other prespecified outcomes

Demographics


Date of birth, sex, race/ethnicity, height/weight/BMI, description of ATd symptoms, goals for physical therapy, previous experience with conservative care, comorbidities X

Four square step test


Participants will perform a series of steps in a square formation. The duration of time needed to complete the step reflects dynamic balance and mobility X

Ultrasound imaging of tendon pathology


Ultrasound imaging will be used to quantify tendon thickness, echogenicity, presence of osteophytes/bone spur X X

Medication


History, current use, and dose of all routine medications and specific questions about opioid use X X X

Treatment history


Treatments previously tried and if they were effective at reducing pain X

Mode of participants’ complete visits


Percentage of participants who completed all visits (evaluation sessions 1 and 2 and follow-up visits) through in-person visits compared with those who completed a percentage of visits through telehealth format
X

aOutcome collected at timepoint.

bOutcome not collected at timepoint.

cAEs: adverse events.

dAT: Achilles tendinopathy.