Background
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Aim 1. To evaluate the immediate (3 months) and extended effects (6 months) of the patient activation intervention on SM adherence.
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Aim 2. To evaluate the effects of the patient activation intervention on hospital readmission and emergency department (ED) visit rates at 30 days, 3 and 6 months.
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Aim 3. To evaluate the mechanism of the patient activation intervention, comparing the intervention and usual care (UC) groups on SM knowledge, self-efficacy for SM, patient activation, and SM strategies at the end of intervention.
Conceptual framework
Methods
Study design
Study setting
Patient inclusion and exclusion
Intervention and usual care
Outcome measures
Randomization, blinding and allocation concealment
Sample size and statistical analysis
Results
Sample characteristics
All (n =100) | Intervention group (n = 51) | Control group (n = 49) | |
---|---|---|---|
Demographic data | |||
Age (years) | 70.2 ± 12.2 | 68.7 ± 11.8 | 71.8 ± 12.6 |
Male | 36 (36) | 24 (47.1) | 12 (24.5) |
Education (years) | 12.9 ± 2.3 | 13 ± 2.4 | 12.8 ± 2.1 |
Caucasian | 95 (95) | 48 (94.1) | 47 (95.9) |
Married/living with partner | 50 (50) | 31 (60.8) | 19 (38.8) |
Currently employed outside home | 29 (29) | 16 (30.8) | 13 (26.5) |
Annual family income (< $30,000) | 51 (51) | 24 (47.10) | 27 (55.1) |
Risk factor profile | |||
Body Mass Index (kg/m2) | 32.3 ± 7.1 | 33.4 ± 7.4 | 31.2 ± 6.8 |
Clinical data | |||
Number of comorbidities | 8 ± 2.6 | 7.8 ± 2.5 | 8.0 ± 2.7 |
1.Hypertension | 99 (99) | 51 (100.0) | 48 (98.0) |
2.Coronary artery disease | 94 (94) | 46 (90.2) | 48 (98) |
3.Arthritis degenerative joint disease | 89 (89) | 43 (84.3) | 44 (89.8) |
4.Hypercholesterolemia | 84 (84) | 43 (84.3) | 41 (83.7) |
5.Diabetes mellitus with or without complications | 41 (41) | 41 (80.4) | 33 (67.4) |
6.Dyspepsia | 50 (50) | 24 (47.1) | 26 (53.1) |
7.Peripheral vascular disease or lower extremity edema | 45 (45) | 22 (43.1) | 23 (46.9) |
8.Chronic obstructive pulmonary disease | 38 (38) | 22 (43.1) | 16 (32.7) |
9.Chronic renal disease | 23 (23) | 12 (23.5) | 11 (22.4) |
Number of medications taking per day | 16.2 (±8.8) | 16.4 ± 10.0 | 15.9 ± 7.4 |
Beta blockers | 50 (50) | 27 (52.9) | 23 (46.9) |
ACE inhibitors | 35 (35) | 16 (31.4) | 19 (38.8) |
Angiotensin receptor blocker | 18 (18) | 8 (15.7) | 10 (20.4) |
Previous hospitalizations within 1 year (≥1) | 43 (43) | 22 (43.2) | 21 (42.8) |
Previous ED visits within 1 year (≥1) | 60 (60) | 30 (58.9) | 30 (61.2) |
Cardiac function | |||
Functional class (NYHA) | |||
•II | 49 (49) | 15 (29.4) | 34 (69.4) |
•III | 42 (42) | 29 (56.9) | 13 (26.5) |
Ejection fractiona | 55.7 ± 11.1 | 53.4 ± 12.9 | 58.3 ± 8.1 |
Ejection fraction < 50 %a | 16 (16) | 12 (23.5) | 4 (8.2) |
Main outcome: Patient Activation Measure (PAM) level | |||
1.Starting to take a role | 39 (39) | 19 (37.3) | 20 (40.8) |
2.Building knowledge, skills and confidence | 23 (23) | 9 (17.6) | 14 (28.6) |
3.Taking action | 18 (18) | 13 (25.5) | 5 (10.2) |
4.Maintaining behaviors | 19 (19) | 10 (19.6) | 9 (18.4) |
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Aim 1. To evaluate the immediate and extended effects of the patient activation intervention on SM adherence.
Variable | Group | Unadjusted Meana (SD) | Estimatedb Marginal Mean (SE) | Group (p-value) | Group X Time (p-value) | Estimated group difference in marginal means [95 % CI] | |
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3 months | 6 months | ||||||
Adherence to self-management behaviors per self-report | |||||||
Days per week weigh self | Intervention | 4.8 ± 2.7 | 4.6 ± 2.4 | 4.7 ± 0.3 | <.0005 | .687 | 2.98 [2.10, 3.86] |
Control | 1.9 ± 2.7 | 1.5 ± 2.5 | 1.7 ± 0.3 | ||||
Days per week follow low-sodium diet | Intervention | 5.6 ± 2.1 | 5.1 ± 2.6 | 5.3 ± 0.3 | <.0005 | .668 | 2.62 [1.74, 3.50] |
Control | 3.1 ± 2.9 | 2.3 ± 3.0 | 2.7 ± 0.3 | ||||
Days missed any medication doses in past 7 days | Intervention | .39 ± 1.2 | .26 ± 1.0 | 0.3 ± 0.2 | .030 | .544 | −0.51 [−0.97, −0.05] |
Control | .81 ± 1.6 | .83 ± 1.4 | 0.8 ± 0.2 | ||||
Days per week exercise | Intervention | 5.4 ± 1.8 | 4.5 ± 2.5 | 4.9 ± 0.3 | <.0005 | .230 | 1.66 [0.79, 2.53] |
Control | 3.4 ± 2.9 | 3.1 ± 2.5 | 3.3 ± 0.3 | ||||
Physical Activity measured by ActiGraphc | |||||||
Average daily activity counts | Intervention | 285,707 ± 152,860 | 306,648 ± 165,316 | 279,160 ± 19,821 | .780 | .693 | 8236 [−50,155; 66,628] |
Control | 251,265 ± 145,744 | 250,913 ± 275,411 | 270,924 ± 271,313 | ||||
Average activity kcals/kg/day | Intervention | 2.2 ± 1.6 | 2.3 ± 1.9 | 2.08 ± 0.2 | .773 | .664 | 0.07 [−0.42, 0.56] |
Control | 1.8 ± 1.7 | 1.7 ± 1.8 | 2.01 ± 0.2 | ||||
Average daily mins ≥ moderate intensity activity | Intervention | 5.8 ± 8.8 | 5.9 ± 10.8 | 4.81 ± 0.9 | .897 | .860 | 0.17 [−2.34, 2.71] |
Control | 3.3 ± 10.5 | 3.7 ± 7.1 | 4.65 ± 0.9 | ||||
Adherence to self-management behaviors measured by biomarkers | |||||||
B-type natriuretic peptide (log-transformed) | Intervention | 1.7 ± 0.7 | 1.7 ± 0.6 | 1.70 ± 0.1 | .282 | .512 | −0.09 [−0.26, 0.08] |
Control | 1.8 ± 0.5 | 1.8 ± 0.4 | 1.80 ± 0.1 | ||||
Average daily sodium intake (<1500 mg) | Intervention | 3607.0 ± 1395.3 | 3748.7 ± 1586.2 | 3647.9 ± 157.3 | .234 | .818 | −272.03 [−722.70, 178.65] |
Control | 3876.9 ± 1097.2 | 3926.6 ± 1279.3 | 3919.9 ± 163.5 |
Variable | Group | Baseline | 3 Months | 6 Months | |
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Days missed any medication doses in past 7 daysa | Intervention | 0 days | 86.3 % (44/51) | 84.3 % (43/51) | 86.0 % (43/50) |
≥1 day | 13.7 % (7/51) | 15.7 % (8/51) | 14.0 (7/50) | ||
Control | 0 days | 81.6 % (40/49) | 68.1 % (32/47) | 68.1 % (32/47) | |
≥1 day | 18.4 % (9/49) | 31.9 % (15/47) | 31.9 % (15/47) | ||
χ2 = .130 (p = .719) b | χ2 = 2.74 (p = .098) b | χ2 = 3.47 (p = .060) b | |||
Kept scheduled appointment with primary care provider (within 30 days) | Intervention | 100 % (51/51) | |||
Control | 97.9 % (46/47) | ||||
Fisher’s exact p = .295c | |||||
Days/wk follow low-sodium diet | Intervention | 0 days | - | 7.8 % (4/51) | 14.0 % (7/50) |
1 – 6 days | - | 35.3 % (18/51) | 30.0 % (15/50) | ||
7 days | - | 56.9 % (29/51) | 56.0 % (28/50) | ||
Control | 0 days | - | 38.3 % (18/47) | 55.3 % (26/47) | |
1 – 6 days | - | 40.4 % (19/47) | 21.3 % (10/47) | ||
7 days | - | 21.3 % (10/47) | 23.4 % (11.47) | ||
χ2 = 18.06 (p < .0005) | χ2 = 19.28 (p < .0005) | ||||
Days/wk exercise | Intervention | 0 days | - | 2.0 % (1/51) | 12.0 % (6/50) |
1 – 6 days | - | 52.9 % (27/51) | 50.0 % (25/50) | ||
7 days | - | 45.1 % (23/51) | 38.0 % (19/50) | ||
Control | 0 days | - | 23.4 % (11/47) | 23.9 % (11/46) | |
1 – 6 days | - | 42.6 % (20/47) | 58.7 % (27/46) | ||
7 days | - | 34.0 % (16/47) | 17.4 % (8/46) | ||
χ2 = 10.49 (p = .005) | χ2 = 5.87 (p = .053) | ||||
Days/wk weigh self | Intervention | 0 days | - | 13.7 % (7/51) | 6.0 % (3/50) |
1 – 6 days | - | 41.2 % (21/51) | 56.0 % (28/50) | ||
7 days | - | 45.1 % (23/51) | 38.0 % (19/50) | ||
Control | 0 days | - | 46.8 % (22/47) | 53.2 % (25/47) | |
1 – 6 days | - | 34.0 % (16/47) | 31.9 % (15/47) | ||
7 days | - | 19.1 % (9/47) | 14.9 % (7/47) | ||
χ2 = 14.42 (p = .001) | χ2 = 26.69 (p < .0005) | ||||
≤1500 mg Na daily | Intervention | Not met | 96.1 % (49/51) | 98.0 % (49/50) | 98.0 % (49/50) |
Met | 3.9 % (2/51) | 2.0 % (1/51) | 2.0 % (1/50) | ||
Control | Not met | 100 % (49/49) | 100 % (47/47) | 100 % (47/47) | |
Met | 0 % (0/49) | 0 % (0/47) | 0 % (0/47) | ||
Fisher’s exact p = .495c | Fisher’s exact p = 1.00c | Fisher’s exact p = 1.00c | |||
Exercise 7 days/wk (self-report) | Intervention | Not met | - | 54.9 % (28/51) | 62.0 % (31/50) |
Met | - | 45.1 % (23/51) | 38.0 % (19/50) | ||
Control | Not met | - | 66.0 % (31/47) | 82.6 % (38/46) | |
Met | - | 34.0 % (16/47) | 17.4 % (8/46) | ||
χ2 = 1.25 (p = .264) | χ2 = 5.03 (p = .025) | ||||
≥120 mins/wk of moderate or more intense activityd | Intervention | Not met | 91.8 % (45/49) | 88.0 % (44/50) | 91.5 % (43/47) |
Met | 8.2 % (4/49) | 12.0 % (6/50) | 8.5 % (4/47) | ||
Control | Not met | 100 % (42/42) | 95.7 % (44/46) | 95.7 % (45/47) | |
Met | 0 % (0/42) | 4.3 % (2/46) | 4.3 % (2/47) | ||
Fisher’s exact p = .121c | Fisher’s exact p = .271c | Fisher’s exact p = .677c |
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Aim 2. To evaluate the effects of the patient activation intervention on hospital readmission and ED rates at 30 days, 3 and 6 months.
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Aim 3. To evaluate the mechanism of the patient activation intervention, comparing the intervention and UC groups on SM knowledge, self-efficacy for self-management, patient activation, and SM strategies at the end of intervention (3 months).
Variable | Possible score range | Group | Number | Baseline Mean (SD) | Number | Month 3 Mean (SD) | Mean change (SD) | t-test (p-value) a |
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Self-management knowledgeb | 0–27 | Intervention | 51 | 21.1 (2.8) | 51 | 23.1 (2.7) | 2.0 (3.4) | .337 |
Control | 49 | 19.4 (3.0) | 47 | 21.1 (2.5) | 1.7 (2.6) | |||
Self-efficacy for HF self-managementc | 0–100 | Intervention | 51 | 44.9 (24.7) | 51 | 59.7 (17.3) | 14.8 (26.0) | .034 |
Control | 49 | 49.2 (22.9) | 47 | 53.8 (24.0) | 5.2 (25.5) | |||
Patient activation (PAM Rasch scaled scores) d | 0–100 | Intervention | 51 | 57.3 (19.2) | 50 | 69.1 (16.7) | 11.7 (21.3) | .069 |
Control | 48 | 56.6 (18.6) | 47 | 61.4 (18.2) | 5.7 (18.5) | |||
Self-management strategies (RSCB) e | 0–145 | Intervention | 50 | 86.8 (19.3) | 51 | 115.7 (19.6) | 28.9 (23.0) | <.0005 |
Control | 49 | 91.9 (19.9) | 47 | 97.6 (22.6) | 5.6 (22.3) |