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Table 6 Outcomes before (day 1) and after (8 weeks) PR program completion for those who received medical clearance to participate

From: Application of the RE-AIM framework to evaluate the implementation of telehealth pulmonary rehabilitation in a randomized controlled trial among African-American and Hispanic patients with advanced stage Chronic Obstructive Pulmonary Disease

 

Trial arm (TelePR n = 62; SPR n = 37)

Day 1, mean (SD)c; median

8 Weeks, mean (SD); median

Change 8 weeks-Day 1, mean (SD)c, median

COPD Assessment Test (CAT)

Maximal Score: 40 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

22.37 (8.35) median: 24.00

19.91 (7.94) median: 21.00

-2.27a (8.43) median: -2, p = 0.04

SPR (n = 37), Mean (± SD)

20.89 (8.53) median: 24.00

20.18 (8.41) median: 20.00

-0.71a (6.5) median: 0, p = 0.38

Effect sizeb

  

Effect size = 0.43

p-value§

0.4031

0.9472

0.4201

Overall p-value

ARM: 0.6977, Time < .0001, Time* ARM: 0.2855

Modified Medical Research Council Scale (MMRC)

Maximal Score: 4 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

2.46 (1.16) median: 3.00

2.28 (1.14) median: 2.00

-0.15a (1.01) median: 0, p = 0.25

SPR (n = 37), Mean (± SD)

2.24 (1.04) median: 2.00

2.24 (1.28) median: 2.00

0.00a (1.37) median: 0, p = 1.00

Effect sizeb

  

Effect size = 0.12

p-value§

0.2273

0.8551

0.4991

Overall p-value

ARM: 0.8494, Time 0.8534, Time* ARM: 0.1719

COPD Self-Efficacy Scale (CSES)

Maximal Score: 170 (higher score denotes improvement)

TelePR (n = 62), Mean (± SD)

93.98 (27.70) median: 96.00

94.16 (29.30) median: 101.00

1.09a (29.11) median: 2.50 p = 0.94

SPR (n = 37), Mean (± SD)

89.42 (33.42) median: 94.00

94.03 (28.59) median: 98.00

5.30a (34.61) median: 0 p = 0.35

Effect sizeb

  

Effect size = 0.13

p-value§

0.5361

0.8793

0.9871

Bristol COPD Knowledge Questionnaire (BCKQ)

Maximal Score: 100 (higher score denotes improvement)

TelePR (n = 62), Mean (± SD)

30.35 (8.89) median: 32.00

34.03 (9.68) median: 36.50

4.19a (8.51) median: 4.00 p = 0.003

SPR (n = 37), Mean (± SD)

30.81 (6.79) median: 30.00

32.33 (7.63) median: 33.00

1.79a (7.74) median: 3.00 p = 0.17

Effect sizeb

  

Effect size = 0.30

p-value§

0.9142

0.2391

0.2311

PROMIS: Depression

Maximal Score: 20 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

8.35 (4.21) median: 8.00

T-score: 55.7 (2.3)

7.97 (4.48) median: 6.50

T-score: 55.7 (2.3)

-0.32a (3.42) median: 0 p = 0.46

SPR (n = 37), Mean (± SD)

7.38 (4.24) median: 6.00

T-score: 53.9 (2.4)

7.85 (3.78) median: 7.00

T-score: 55.7 (2.3)

0.52a (3.96) median: 0, p = 0.46

Effect sizeb

  

Effect size = 0.23

p-value§

0.2533

0.8361

0.4087

Overall p-value

ARM: 0.9561, Time 0.1274, Time* ARM: 0.3290

PROMIS: Fatigue

Maximal Score: 20 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

11.77 (4.95) median: 10.50

T-score: 57.0 (2.3)

10.43 (4.53) median: 10.50

T-score: 53.1 (2.4)

-1.34a (4.22) median: -1 p = 0.02

SPR (n = 37),

Mean (± SD)

9.70 (4.47) median: 9.00

T-score: 53.1 (2.4)

10.88 (4.21) median: 11.00

T-score:55.1 (2.4)

1.45a (5.41) median: 1, p = 0.13

Effect sizeb

  

Effect size = 0.58

p-value§

0.0707

0.5933

0.0071

Overall p-valuell

ARM: 0.6812, Time 0.5964, Time* ARM: 0.0380

PROMIS: Informational Support

Maximal Score: 20 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

14.95 (5.24) median: 17.50

T-score: 50.3 (2.4)

16.10 (4.61) median: 17.00

T-score: 52.4 (2.4)

1.00a (5.38) median: 0

p = 0.16

SPR (n = 37), Mean (± SD)

15.76 (4.79) median: 16.00

T-score: 52.4 (2.4)

15.64 (4.70) median: 17.00

T-score: 52.4 (2.4)

-0.15a (4.37) median: 0, p = 0.84

Effect sizeb

  

Effect size = 0.17

p-value§

0.4224

0.5797

0.6808

Overall p-value ll

ARM: 0.3643, Time 0.4149, Time* ARM: 0.4772

PROMIS: Social Isolation

Maximal Score: 20 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

7.97 (4.34) median: 6.00

T-score: 47.8 (2.6)

8.66 (4.56) median: 7.00

T-score: 49.8 (2.6)

1.03a (3.60) median: 0 p = 0.03

SPR (n = 37), Mean (± SD)

7.39 (3.77) median: 7.00

T-score: 45.7 (2.7)

8.79 (4.54) median: 8.00

49.8 (2.6)

1.39a (5.06) median: 1, p = 0.12

Effect sizeb

  

Effect size = 0.08

p-value§

0.7009

0.7768

0.583

Overall p-value ll

ARM: 0.8534, Time 0.0622, Time*ARM: 0.3248

PROMIS: Instrumental Support

Maximal Score: 20 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

15.60 (4.90) median: 17.50

T-score: 50.5 (2.4)

15.53 (5.01) median: 17.00

T-score: 50.5 (2.4)

-0.22a (3.12) median: 0 p = 0.70

SPR (n = 37), Mean (± SD)

15.70 (5.24) median: 17.00

T-score: 50.5 (2.4)

16.00 (4.37) median: 18.00

T-score: 50.5 (2.4)

0.67a (4.81) median: 0, p = 0.53

Effect sizeb

  

Effect size = 0.22

p-value§

0.8612

0.9628

0.65

Overall p-value ll

ARM: 0.8475, Time 0.9577, Time* ARM: 0.6395

PROMIS: Anxiety

Maximal Score: 20 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

8.71 (4.21) median: 8.00

T-score: 57.7 (2.6)

8.29 (4.40) median: 7.00

T-score: 55.8 (2.7)

-0.52a (3.30), median: 0 p = 0.38

SPR (n = 37), Mean (± SD)

8.38 (4.70) median: 8.00

T-score: 55.8 (2.7)

8.85 (4.14) median: 8.00

T-score: 57.7 (2.6)

0.33a (3.89) median: 0, p = 0.84

Effect sizeb

  

Effect size = 0.24

p-value§

0.6369

0.3217

0.86

Overall p-value ll

ARM: 0.7752, Time 0.9675, Time* ARM: 0.7143

PROMIS: Companionship

Maximal Score: 20 (lower score denotes improvement)

TelePR (n = 62), Mean (± SD)

14.26 (4.76) median: 14.00

T-score: 46.2 (2.2)

14.88 (4.68) median: 16.00

T-score: 48.1 (2.2)

0.74a (3.58) median: 0 p = 0.21

SPR (n = 37), Mean (± SD)

14.14 (4.93) median: 14.00

T-score: 46.2 (2.2)

13.27 (4.42) median: 14.00

T-score: 44.3 (2.2

-0.33a (5.21) median: 0, p = 0.84

Effect sizeb

  

Effect size = 0.24

p-value§

0.9275

0.073

0.41

Overall p-value ll

ARM: 0.9979, Time 0.5391, Time* ARM: 0.1219

Functional Capacity (TelePR: 2MST (steps); SPR: 6MWT (meters))

(higher denotes improvement)

TelePR (n = 62), Mean (± SD)

43.87 (17.42) median: 42.00

51.12 (23.46) median: 50.00

1.22a (± 29.5%) median: 1.22 p = 0.001**

SPR (n = 37), Mean (± SD)

261.92 (125.85) median: 269.00

275.29 (137.85) median: 320.00

0.98a (± 130%) median: 1.12

p = 0.911**

Effect sizeb

  

Effect size = 0.003

p-value§

  

0.22

  1. All p-values are for descriptive purposes and should be interpreted with caution
  2. Abbreviations: 2MST 2 min-step test, 6MWT 6 min-walk test
  3. Paired t-test or signed rank test
  4. §Two-sample t-test or Wilcoxon rank sum test
  5. llp-values for each variable from repeated measures analysis of variance “MMRMA” (p-value for Arm: if there was difference between two arms in the outcome variable, p-value for Time: if the outcome changed from 8 weeks to day 1; p-value for Arm*Time: if the changes of the outcome variable over time differ between the two arms. For example, for CAT, no difference in CAT between the two arms, a significant improvement in CAT over time, but the changes over time did not differ between the two arms
  6. **Paired t-test using log transformation
  7. aChange in 8 weeks-Day1: negative values denote improvement; positive values denote worsening; Geometric mean of the ratio 8-week score to day 1 score; larger values indicate improvement
  8. bEffect Size: Cohen’s D for two-sample t-test = difference in the mean/pooled standard deviation
  9. cFunctional capacity was analyzed as percent change from baseline to 8 weeks. The data was analyzed using a log transformation of the data and results are presented as geometric means and geometric standard deviations. This analysis is based on the log-fold change from baseline to 8 weeks in number of steps (for 2 min walk test). 1.22 represents the geometric mean fold change from baseline (i.e., a 22% increase). ± 29.5% allows us to say that 95% of the population would lie between a 0.16 fold change and a 9.46 fold change, where the 0.16 represents an 84% decrease in distance walked in 6 min and 9.46 represents an 846% increase in distance. For the SPR group the same interpretation applies where 0.98 represents the geometric mean fold change from baseline (i.e., a 2% decrease). ± 130% allows us to say that 95% of the population would lie between a 0.6 fold change and a 1.59 fold change where the 0.6 represents a 40% decrease in steps and 9.46 represents a 59% increase in steps climbed in 2 min