Tailoring Online Continence Promotion (TOCP)

Author

Lu Mao

Published

December 17, 2024

Statistical analysis

Description of methods.

Baseline characteristics

Demographics and health information

Patient demographics, health status, medical and surgical histories at baseline (Sec. 5 of baseline_survey) are summarized in Table 1.

Table 1:

Patient demographics and health information by randomized arm.

Characteristic Control, N = 2261 Tailored, N = 2191 p-value2
Age (years) 58 (54, 65) 58 (54, 63) 0.7
Race

0.8
    American Indian or Alaska Native 4 (1.8%) 2 (0.9%)
    Asian or Asian American 3 (1.3%) 3 (1.4%)
    Black or African American 41 (18%) 34 (16%)
    White 174 (77%) 175 (80%)
    Other/More than one 2 (0.9%) 4 (1.8%)
    Do not wish to provide 2 (0.9%) 1 (0.5%)
Hispanic/Latino 5 (2.2%) 4 (1.9%) >0.9
    Unknown 2 3
Height (cm) 165 (160, 170) 165 (160, 170) 0.2
Weight (kg) 77 (64, 93) 75 (63, 89) 0.5
    Unknown 24 20
Body mass index (kg/m^2) 28 (24, 33) 27 (23, 32) 0.2
    Unknown 24 20
Education

0.12
    High school diploma or GED 4 (1.8%) 7 (3.2%)
    Vocational school or other specialized training 10 (4.4%) 5 (2.3%)
    Some college 13 (5.8%) 23 (11%)
    College degree (Associate's or Bachelor's) 85 (38%) 67 (31%)
    Master's or Doctorate degree 114 (50%) 117 (53%)
Work status

0.4
    Retired 60 (27%) 60 (27%)
    Not working due to a disability 3 (1.3%) 6 (2.7%)
    Not working for another reason 5 (2.2%) 5 (2.3%)
    Stay at home parent or caregiver 5 (2.2%) 1 (0.5%)
    Working full-time 131 (58%) 118 (54%)
    Working part-time 22 (9.7%) 29 (13%)
Have a primary care provider 185 (82%) 187 (85%) 0.3
Health insurance

0.8
    Medicare/Medicaid 94 (42%) 87 (40%)
    Other types of insurance 129 (57%) 127 (58%)
    I am not sure 1 (0.4%) 2 (0.9%)
    None 2 (0.9%) 3 (1.4%)
Number of pregnancies

0.4
    0 31 (14%) 22 (10%)
    1 26 (12%) 36 (16%)
    2-3 130 (58%) 126 (58%)
    4+ 38 (17%) 35 (16%)
    Choose not to answer 1 (0.4%) 0 (0%)
Overall health in past 4 weeks (self-rated)

0.12
    Excellent 26 (12%) 37 (17%)
    Very good 68 (30%) 75 (34%)
    Good 93 (41%) 79 (36%)
    Fair 36 (16%) 23 (11%)
    Poor 2 (0.9%) 5 (2.3%)
    Very poor 1 (0.4%) 0 (0%)
High blood pressure 57 (25%) 58 (26%) 0.8
Diabetes 12 (5.3%) 13 (5.9%) 0.8
Obesity 46 (20%) 40 (18%) 0.6
Memory problems 16 (7.1%) 11 (5.0%) 0.4
Anxiety 72 (32%) 60 (27%) 0.3
Depression 66 (29%) 52 (24%) 0.2
Cancer 5 (2.2%) 7 (3.2%) 0.5
Chronic pain 32 (14%) 40 (18%) 0.2
Hysterectomy 36 (16%) 36 (16%) 0.9
Cholecystectomy 30 (13%) 20 (9.1%) 0.2
Surgery for pelvic organ prolapse 5 (2.2%) 6 (2.7%) 0.7
Mesh sling for urinary incontinence 7 (3.1%) 6 (2.7%) 0.8
Other surgery for urinary incontinence 15 (6.6%) 10 (4.6%) 0.3
Surgery for bowel incontinence 0 (0%) 3 (1.4%) 0.12
1 Median (IQR); n (%)
2 Wilcoxon rank sum test; Fisher’s exact test; Pearson’s Chi-squared test

Health behavior

Health behaviors that may impact bladder or bowel health at baseline (Sec. 2 of baseline_survey) are summarized by randomized arm in Table 2.

Table 2:

Baseline health behaviors by randomized arm.

Characteristic Control, N = 2261 Tailored, N = 2191 p-value2
Kegel squeezes in last 4 weeks

0.8
    Once per month or less 103 (46%) 92 (42%)
    A few times per month 44 (19%) 49 (22%)
    At least once per week 25 (11%) 25 (11%)
    Several times per week 26 (12%) 23 (11%)
    At least once per day 9 (4.0%) 15 (6.8%)
    Several times per day 16 (7.1%) 13 (5.9%)
    Choose not to answer 3 (1.3%) 2 (0.9%)
Daily fiber intake

>0.9
    Less than I should 66 (29%) 62 (28%)
    About what I should 130 (58%) 125 (57%)
    More than I should 29 (13%) 31 (14%)
    Choose not to answer 1 (0.4%) 1 (0.5%)
Daily fluid intake

0.7
    Less than I should 48 (21%) 54 (25%)
    About what I should 141 (62%) 129 (59%)
    More than I should 37 (16%) 36 (16%)
Estimated total fluid intake 60.0 (40.0, 96.0) 64.0 (40.0, 91.0) >0.9
Servings of coffee last week

0.8
    I do not drink coffee 49 (22%) 42 (19%)
    Less than 3 servings per week 46 (20%) 37 (17%)
    3-6 servings per week 31 (14%) 40 (18%)
    1 serving (12 ounces) per day 36 (16%) 36 (16%)
    2 servings (24 ounces) per day 51 (23%) 50 (23%)
    3 or more servings (36 ounces) per day 13 (5.8%) 14 (6.4%)
Servings of soda last week

>0.9
    I do not drink soda with caffeine 86 (38%) 85 (39%)
    Less than 3 servings per week 59 (26%) 56 (26%)
    3-6 servings per week 36 (16%) 34 (16%)
    1 serving (12 ounces) per day 21 (9.3%) 25 (11%)
    2 servings (24 ounces) per day 18 (8.0%) 13 (5.9%)
    3 or more servings (36 ounces) per day 6 (2.7%) 6 (2.7%)
Fruit last 4 weeks

0.8
    Less than 1 serving per week 30 (13%) 24 (11%)
    1 serving per week 13 (5.8%) 14 (6.4%)
    2-3 servings per week 43 (19%) 47 (21%)
    4-6 servings per week 30 (13%) 37 (17%)
    1 serving per day 44 (19%) 43 (20%)
    More than 1 serving per day 65 (29%) 54 (25%)
    Choose not to answer 1 (0.4%) 0 (0%)
Green salad last 4 weeks

0.4
    Less than 1 serving per week 18 (8.0%) 20 (9.1%)
    1 serving per week 33 (15%) 35 (16%)
    2-3 servings per week 65 (29%) 62 (28%)
    4-6 servings per week 43 (19%) 54 (25%)
    1 serving per day 46 (20%) 35 (16%)
    More than 1 serving per day 21 (9.3%) 13 (5.9%)
Potato last 4 weeks

0.2
    Less than 1 serving per week 26 (12%) 22 (10%)
    1 serving per week 35 (15%) 47 (21%)
    2-3 servings per week 70 (31%) 66 (30%)
    4-6 servings per week 38 (17%) 47 (21%)
    1 serving per day 43 (19%) 26 (12%)
    More than 1 serving per day 14 (6.2%) 11 (5.0%)
Vegetable last 4 weeks

>0.9
    Less than 1 serving per week 2 (0.9%) 3 (1.4%)
    1 serving per week 11 (4.9%) 13 (5.9%)
    2-3 servings per week 53 (23%) 51 (23%)
    4-6 servings per week 50 (22%) 46 (21%)
    1 serving per day 43 (19%) 46 (21%)
    More than 1 serving per day 67 (30%) 60 (27%)
Vegetable juice last 4 weeks

0.4
    Less than 1 serving per week 129 (57%) 128 (58%)
    1 serving per week 27 (12%) 23 (11%)
    2-3 servings per week 17 (7.5%) 23 (11%)
    4-6 servings per week 13 (5.8%) 15 (6.8%)
    1 serving per day 15 (6.6%) 16 (7.3%)
    More than 1 serving per day 23 (10%) 11 (5.0%)
    Choose not to answer 2 (0.9%) 3 (1.4%)
Vegetable soup last 4 weeks

0.6
    Less than 1 serving per week 56 (25%) 68 (31%)
    1 serving per week 58 (26%) 54 (25%)
    2-3 servings per week 47 (21%) 44 (20%)
    4-6 servings per week 20 (8.8%) 21 (9.6%)
    1 serving per day 20 (8.8%) 13 (5.9%)
    More than 1 serving per day 25 (11%) 18 (8.2%)
    Choose not to answer 0 (0%) 1 (0.5%)
Fiber cereal last 4 weeks

>0.9
    Less than 1 serving per week 85 (38%) 80 (37%)
    1 serving per week 22 (9.7%) 19 (8.7%)
    2-3 servings per week 38 (17%) 42 (19%)
    4-6 servings per week 29 (13%) 29 (13%)
    1 serving per day 32 (14%) 33 (15%)
    More than 1 serving per day 18 (8.0%) 13 (5.9%)
    Choose not to answer 2 (0.9%) 3 (1.4%)
Whole wheat/rye bread last 4 weeks


    Less than 1 serving per week 47 (21%) 41 (19%)
    1 serving per week 26 (12%) 31 (14%)
    2-3 servings per week 59 (26%) 60 (27%)
    4-6 servings per week 30 (13%) 39 (18%)
    1 serving per day 34 (15%) 35 (16%)
    More than 1 serving per day 28 (12%) 12 (5.5%)
    Choose not to answer 2 (0.9%) 1 (0.5%)
Beans last 4 weeks

0.6
    Less than 1 serving per week 39 (17%) 41 (19%)
    1 serving per week 46 (20%) 42 (19%)
    2-3 servings per week 54 (24%) 64 (29%)
    4-6 servings per week 38 (17%) 27 (12%)
    1 serving per day 27 (12%) 26 (12%)
    More than 1 serving per day 21 (9.3%) 16 (7.3%)
    Choose not to answer 1 (0.4%) 3 (1.4%)
I use panty liners 109 (48%) 93 (42%) 0.2
I use pads 88 (39%) 68 (31%) 0.081
I use undergarments (e.g., Depends/diapers) 69 (31%) 47 (21%) 0.029
I use something else 11 (4.9%) 10 (4.6%) 0.9
I do not use anything 72 (32%) 87 (40%) 0.083
Number of panty liners used per 24 h 0.0 (0.0, 2.0) 0.0 (0.0, 2.0) 0.12
    Unknown 15 13
Number of pads used per 24 h 0.0 (0.0, 2.0) 0.0 (0.0, 2.0) 0.15
    Unknown 13 11
Number of undergarments used per 24 h 0.0 (0.0, 2.0) 0.0 (0.0, 1.0) 0.030
    Unknown 14 13
Money spent on managing symptoms last month


    None 76 (34%) 86 (39%)
    Less than $5 16 (7.1%) 11 (5.0%)
    $5 - $10 25 (11%) 22 (10%)
    $11 - $20 20 (8.8%) 21 (9.6%)
    $21 - $30 19 (8.4%) 10 (4.6%)
    $31 - $50 21 (9.3%) 22 (10%)
    $51 - $100 22 (9.7%) 22 (10%)
    $101 - $200 20 (8.8%) 14 (6.4%)
    More than $200 2 (0.9%) 2 (0.9%)
    Choose not to answer 5 (2.2%) 9 (4.1%)
Number of urinations overnight 2.0 (1.0, 3.0) 1.0 (1.0, 3.0) 0.3
Number of urinations during daytime

0.14
    less than 4 times per day 30 (13%) 20 (9.1%)
    4-5 times 59 (26%) 68 (31%)
    6-8 times 82 (36%) 95 (43%)
    9-10 times 40 (18%) 29 (13%)
    11-12 times 13 (5.8%) 7 (3.2%)
    more than 12 times per day 1 (0.4%) 0 (0%)
    Choose not to answer 1 (0.4%) 0 (0%)
Time between urinations


    less than 4 times per day 37 (16%) 33 (15%)
    4-5 times 49 (22%) 66 (30%)
    6-8 times 85 (38%) 89 (41%)
    9-10 times 42 (19%) 18 (8.2%)
    11-12 times 10 (4.4%) 12 (5.5%)
    Choose not to answer 3 (1.3%) 1 (0.5%)
1 n (%); Median (IQR)
2 Fisher’s exact test; Pearson’s Chi-squared test; Wilcoxon rank sum test

Bladder Symptoms

Bladder symptoms at baseline (Sec. 3 of baseline_survey) are summarized by randomized arm in Table 3.

Table 3:

Baseline bladder symptoms by randomized arm.

Characteristic Control, N = 2261 Tailored, N = 2191 p-value2
Leakage


    Never 13 (5.8%) 27 (12%)
    About once a week or less often 69 (31%) 68 (31%)
    Two or three times a week 59 (26%) 51 (23%)
    About once a day 30 (13%) 33 (15%)
    Several times a day 40 (18%) 30 (14%)
    All the time 14 (6.2%) 8 (3.7%)
    Choose not to answer 1 (0.4%) 2 (0.9%)
Amount of leakage

0.071
    None 12 (5.3%) 22 (10%)
    A small amount 144 (64%) 148 (68%)
    A moderate amount 51 (23%) 36 (16%)
    A large amount 19 (8.4%) 12 (5.5%)
    Choose not to answer 0 (0%) 1 (0.5%)
Leakage interferes with daily life (0-10) 3.0 (1.0, 6.0) 3.0 (1.0, 5.0) 0.043
    Unknown 0 1
iciq score BL 8.0 (5.0, 12.0) 7.0 (4.0, 10.3) 0.025
    Unknown 1 3
Urine does not leak 13 (5.8%) 23 (11%) 0.066
Leaks before getting to toilet 109 (48%) 103 (47%) 0.8
Leaks when you cough or sneeze 122 (54%) 115 (53%) 0.8
Leaks when asleep 45 (20%) 43 (20%) >0.9
Leaks when physically active/exercising 87 (38%) 74 (34%) 0.3
Leaks when finished urinating and dressed 42 (19%) 29 (13%) 0.12
Leaks for no obvious reason 64 (28%) 38 (17%) 0.006
Leaks all the time 10 (4.4%) 9 (4.1%) 0.9
Confidence in controlling urine (0-10) 5.0 (4.0, 8.0) 6.0 (3.0, 8.0) 0.8
    Unknown 1 1
Confidence in preventing urine loss (0-10) 5.0 (3.0, 8.0) 6.0 (3.0, 9.0) 0.3
    Unknown 5 1
Ability to do household chores

0.6
    Not at all 136 (60%) 136 (62%)
    Somewhat 35 (15%) 29 (13%)
    Moderately 30 (13%) 23 (11%)
    Quite a bit/Greatly 25 (11%) 31 (14%)
Ability to walk/swim/exercise

0.6
    Not at all 89 (39%) 82 (37%)
    Somewhat 69 (31%) 78 (36%)
    Moderately 38 (17%) 35 (16%)
    Quite a bit/Greatly 30 (13%) 23 (11%)
    Choose not to answer 0 (0%) 1 (0.5%)
Ability to go to movies/concerts

0.7
    Not at all 103 (46%) 108 (49%)
    Somewhat 55 (24%) 55 (25%)
    Moderately 42 (19%) 35 (16%)
    Quite a bit/Greatly 26 (12%) 20 (9.1%)
    Choose not to answer 0 (0%) 1 (0.5%)
Ability to travel by car/bus 30min away

0.026
    Not at all 85 (38%) 106 (48%)
    Somewhat 62 (27%) 62 (28%)
    Moderately 57 (25%) 33 (15%)
    Quite a bit/Greatly 22 (9.7%) 17 (7.8%)
    Choose not to answer 0 (0%) 1 (0.5%)
Ability to socialize outside home

0.7
    Not at all 97 (43%) 104 (47%)
    Somewhat 59 (26%) 57 (26%)
    Moderately 40 (18%) 34 (16%)
    Quite a bit/Greatly 30 (13%) 23 (11%)
    Choose not to answer 0 (0%) 1 (0.5%)
Emotional health (nervousness, depression, etc)

0.093
    Not at all 100 (44%) 113 (52%)
    Somewhat 51 (23%) 56 (26%)
    Moderately 40 (18%) 25 (11%)
    Quite a bit/Greatly 35 (15%) 24 (11%)
    Choose not to answer 0 (0%) 1 (0.5%)
Feeling frustrated

0.4
    Not at all 76 (34%) 85 (39%)
    Somewhat 68 (30%) 70 (32%)
    Moderately 44 (19%) 37 (17%)
    Quite a bit/Greatly 38 (17%) 26 (12%)
    Choose not to answer 0 (0%) 1 (0.5%)
Sought help with health professionals

0.13
    No 77 (34%) 96 (44%)
    Yes, but not very helpful 57 (25%) 45 (21%)
    Yes, and helpful 90 (40%) 74 (34%)
    Choose not to answer 2 (0.9%) 4 (1.8%)
No health care practitioner to help me

0.6
    Not at all 134 (59%) 133 (61%)
    Somewhat 39 (17%) 40 (18%)
    Moderately 23 (10%) 13 (5.9%)
    Quite a bit/Greatly 25 (11%) 27 (12%)
    Choose not to answer 5 (2.2%) 6 (2.7%)
Long delays before insurance repays

0.2
    Not at all 115 (51%) 121 (55%)
    Somewhat 46 (20%) 34 (16%)
    Moderately 24 (11%) 33 (15%)
    Quite a bit/Greatly 31 (14%) 19 (8.7%)
    Choose not to answer 10 (4.4%) 12 (5.5%)
Insurance too complicated to figure out

>0.9
    Not at all 118 (52%) 117 (53%)
    Somewhat 52 (23%) 51 (23%)
    Moderately 37 (16%) 36 (16%)
    Quite a bit/Greatly 17 (7.5%) 13 (5.9%)
    Choose not to answer 2 (0.9%) 2 (0.9%)
Cost of leakage evaluation too high

0.7
    Not at all 113 (50%) 122 (56%)
    Somewhat 46 (20%) 43 (20%)
    Moderately 32 (14%) 29 (13%)
    Quite a bit/Greatly 26 (12%) 18 (8.2%)
    Choose not to answer 9 (4.0%) 7 (3.2%)
No transportation to office or clinic

0.8
    Not at all 161 (71%) 156 (71%)
    Somewhat 25 (11%) 26 (12%)
    Moderately 22 (9.7%) 16 (7.3%)
    Quite a bit/Greatly 17 (7.5%) 18 (8.2%)
    Choose not to answer 1 (0.4%) 3 (1.4%)
Long waiting times for appointments

0.6
    Not at all 121 (54%) 121 (55%)
    Somewhat 43 (19%) 31 (14%)
    Moderately 32 (14%) 38 (17%)
    Quite a bit/Greatly 26 (12%) 24 (11%)
    Choose not to answer 4 (1.8%) 5 (2.3%)
Office/Clinic too far away

0.087
    Not at all 145 (64%) 133 (61%)
    Somewhat 28 (12%) 32 (15%)
    Moderately 29 (13%) 38 (17%)
    Quite a bit/Greatly 24 (11%) 13 (5.9%)
    Choose not to answer 0 (0%) 3 (1.4%)
Appointment schedule too far ahead

0.4
    Not at all 89 (39%) 84 (38%)
    Somewhat 60 (27%) 64 (29%)
    Moderately 39 (17%) 44 (20%)
    Quite a bit/Greatly 35 (15%) 22 (10%)
    Choose not to answer 3 (1.3%) 5 (2.3%)
Office hours too limited

>0.9
    Not at all 117 (52%) 118 (54%)
    Somewhat 45 (20%) 41 (19%)
    Moderately 36 (16%) 34 (16%)
    Quite a bit/Greatly 25 (11%) 22 (10%)
    Choose not to answer 3 (1.3%) 4 (1.8%)
Don't like to be examined/asked many questions

0.5
    Not at all 135 (60%) 130 (59%)
    Somewhat 42 (19%) 45 (21%)
    Moderately 25 (11%) 22 (10%)
    Quite a bit/Greatly 24 (11%) 19 (8.7%)
    Choose not to answer 0 (0%) 3 (1.4%)
Physician/nurse doesn't take time with me

0.12
    Not at all 143 (63%) 137 (63%)
    Somewhat 37 (16%) 30 (14%)
    Moderately 24 (11%) 28 (13%)
    Quite a bit/Greatly 21 (9.3%) 16 (7.3%)
    Choose not to answer 1 (0.4%) 8 (3.7%)
Afraid of serious problem

0.2
    Not at all 130 (58%) 131 (60%)
    Somewhat 42 (19%) 43 (20%)
    Moderately 30 (13%) 24 (11%)
    Quite a bit/Greatly 24 (11%) 17 (7.8%)
    Choose not to answer 0 (0%) 4 (1.8%)
Afraid of health care practitioner

0.038
    Not at all 166 (73%) 156 (71%)
    Somewhat 28 (12%) 21 (9.6%)
    Moderately 11 (4.9%) 21 (9.6%)
    Quite a bit/Greatly 21 (9.3%) 16 (7.3%)
    Choose not to answer 0 (0%) 5 (2.3%)
HCP not interested in my problem

0.13
    Not at all 151 (67%) 147 (67%)
    Somewhat 34 (15%) 31 (14%)
    Moderately 23 (10%) 22 (10%)
    Quite a bit/Greatly 18 (8.0%) 13 (5.9%)
    Choose not to answer 0 (0%) 6 (2.7%)
1 n (%); Median (IQR)
2 Fisher’s exact test; Wilcoxon rank sum test; Pearson’s Chi-squared test

Bowel Symptoms

Bowel symptoms at baseline (Sec. 4 of baseline_survey) are summarized by randomized arm in Table 4.

Table 4:

Baseline bowel symptoms by randomized arm.

Characteristic Control, N = 2261 Tailored, N = 2191
Solid stool incontinence

    Never (less than once per month) 145 (64%) 154 (70%)
    Rarely (about once a month) 31 (14%) 26 (12%)
    Sometimes (2-3 times a month) 25 (11%) 19 (8.7%)
    Weekly 7 (3.1%) 6 (2.7%)
    Daily 18 (8.0%) 13 (5.9%)
    Choose not to answer 0 (0%) 1 (0.5%)
Liquid stool incontinence

    Never (less than once per month) 115 (51%) 124 (57%)
    Rarely (about once a month) 41 (18%) 35 (16%)
    Sometimes (2-3 times a month) 37 (16%) 32 (15%)
    Weekly 18 (8.0%) 14 (6.4%)
    Daily 15 (6.6%) 13 (5.9%)
    Choose not to answer 0 (0%) 1 (0.5%)
Gas incontinence

    Never (less than once per month) 40 (18%) 42 (19%)
    Rarely (about once a month) 49 (22%) 54 (25%)
    Sometimes (2-3 times a month) 59 (26%) 59 (27%)
    Weekly 34 (15%) 31 (14%)
    Daily 44 (19%) 33 (15%)
Bowel symptoms affecting lifestyle

    Never (less than once per month) 81 (36%) 83 (38%)
    Rarely (about once a month) 41 (18%) 51 (23%)
    Sometimes (2-3 times a month) 61 (27%) 50 (23%)
    Weekly 21 (9.3%) 16 (7.3%)
    Daily 22 (9.7%) 19 (8.7%)
Use of pads/plugs 66 (29%) 58 (27%)
    Unknown 0 4
Use of medications 63 (28%) 51 (24%)
    Unknown 0 2
Have to rush to toilet when having urge 103 (46%) 98 (45%)
    Unknown 0 1
SMIS total score 7.0 (2.0, 13.0) 5.0 (2.0, 12.0)
    Unknown 0 7
Confidence in controlling bowel (0-10) 8.0 (5.0, 10.0) 8.0 (5.0, 9.0)
    Unknown 3 1
Confidence in preventing bowel loss (0-10) 8.0 (5.0, 10.0) 8.0 (6.0, 10.0)
    Unknown 4 1
Sought help with health professionals

    No 131 (58%) 140 (64%)
    Yes, but not very helpful 27 (12%) 24 (11%)
    Yes, and helpful 66 (29%) 55 (25%)
    Choose not to answer 2 (0.9%) 0 (0%)
1 n (%); Median (IQR)

Engagement in first 4 weeks (Aim 1)

Presence/absence of a click

For each day after randomization (baseline_survey_timestamp), we determine if a patient clicked on the website. Their click patterns over time by randomization status are shown in Figure 1.

Figure 1: Patient-level engagement over time by randomization status.

Proportion of patients with at least one click per day/week over time by randomization status is shown in Figure 2.

Figure 2: Proportion of patients with at least one click over time by randomization status.

Figure 1 and Figure 2 show that most patients clicked on the website within the first week after randomization. The proportion of patients who clicked on the website decreased over time. The proportion of patients who clicked on the website was simiar between the two arms.

In the first 4 weeks following randomization, the number and proportion of patients who clicked on the website at least once for all 4 weeks (primary endpoint) and at least 3 or 2 weeks are summarized in Table 5 and visualized in Figure 3.

Table 5:

Engagement in the first 4 weeks by randomization status.

Characteristic Control, N = 2261 Tailored, N = 2191 p-value2
All 4 weeks (Primary endpoint) 17 (7.5%) 35 (16%) 0.005
At least 3 weeks 70 (31%) 70 (32%) 0.8
At least 2 weeks 121 (54%) 127 (58%) 0.3
1 n (%)
2 Pearson’s Chi-squared test

Figure 3: Proportion of patients engaged in the first 4 weeks by randomization status.

There is a higher percentage of patients who clicked on the website for all 4 weeks in the intervention arm compared to the control arm. The difference in the proportion of patients who clicked on the website for at least 3 or 2 weeks between the two arms is not as pronounced.