Cardiovascular Risk Education and Social Support (CaRESS): Report of a Randomized Controlled Trial from the Kentucky Ambulatory Network (KAN)

Kevin A. Pearce; Margaret M. Love; Brent J. Shelton; Nancy E. Schoenberg; Mary A. Williamson; Mary A. Barron; Jessica M. Houlihan

doi:10.3122/jabfm.2008.04.080007

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Table 1.

Data Collected for Each Participant, by Study Visit

	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5	Visit 6	Visit 7
Time since randomization^* (months)	Baseline	Baseline	Baseline	6	6	12	12
Resting BP	A, B, C	A, B, C	A, B, C	A, B, C	A, B, C	A, B, C	A, B, C
Fasting lipid profile		A, B, C	A, B, C	A, B, C	A, B, C	A, B, C	A, B, C
HbA1C		A, B, C		A, B, C		A, B, C
CVD history	A, B, C
Interval CVD history					A, B, C		A, B, C
Medication review	A, B, C				A, B, C		A, B, C
Medication adherence			A, B, C		B		A, B, C
HRQL	A, B, C				A, B, C		A, B, C
Healthcare satisfaction	A, B, C						A, B, C
Health-related self-efficacy	A, B, C				B		B
Social network	A, B, C				B		A, B, C
SP qualities/involvement	A, B, C				B		A, B, C
Demographics	A, B, C				A, B, C		A, B, C

Patient education session occurred during visit 3.
* Randomization occurred after visit 2.
BP, blood pressure; CVD, cardiovascular disease; HRQL, health-related quality of life; SP, support person; A, intervention group A; B, intervention group B; C, control group.

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Table 2.

Method and/or Instrument(s) Used for Non-physiologic Measures

Measure	Method(s)/Instrument(s)
CVD history	Patient structured interview with research staff
Interval CVD history	Patient structured interview with research staff
Medication review	Patient structured interview with research staff
Medication adherence	Medication Adherence Questionnaire³⁷
HRQL	SF-36 Health Survey^38,39
Healthcare satisfaction	Patient Healthcare Satisfaction Survey⁴⁰ over telephone
Self-efficacy	Perceived Health Competence Scale⁴¹
Social support network	Self-report at baseline on whether person(s) already helping patient with CVD risk management and person patient would ask to be SP (friend vs. relative)
SP qualities/involvement	Social Support for Intervention Survey³²
Demographics	Patient structured interview with research staff

CVD, cardiovascular disease; HRQL, health-related quality of life; SP, support person.

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Table 3.

Patient Participant Baseline Characteristics and Values

	Total Sample	Group A	Group B	Groups A and B Combined (AB)	Group C (Control)	P (A vs B vs C)	P (AB vs C)
N	199^*	50	58	108	91
Age in years (mean [SD])	62.1 (10.79)	60.3 (9.44)	62.0 (11.51)	61.2 (10.59)	63.1 (10.98)	.4400	.2644
Gender (%)
Female	55.3	48.0	65.5	57.4	52.8	.1521	.5678
Race (%)
White	86.9	88.0	82.8	85.2	89.0	.5257	.5279
African-American	13.1	12.0	17.2	14.8	11.0
Employment (%)
Employed	37.5	47.9	35.2	41.2	33.3	.3176	.2301
Retired	47.9	37.5	46.3	42.2	54.4
Unemployed/disabled	14.6	14.6	18.5	16.7	12.3
Education (%)
≤ Some high school	16.6	20.0	13.8	16.7	16.5	.9030	.9663
High school grad/GED	41.2	44.0	39.7	41.7	40.7
2-year degree/some college	22.6	16.0	25.9	21.3	24.2
≥ 4-year college graduate	19.6	20.0	20.7	20.4	18.7
Health insurance (%)
Group/private	60.9	53.1	51.9	52.5	70.3	.0046	.0303
Medicaid/Medicare	32.8	32.7	42.3	37.6	27.5
Other	1.0	0.0	3.7	2.0	0.0
None	5.2	14.3	1.9	7.9	2.2

Has current SP (% Yes)	29.7	26.0	34.5	30.6	28.6	.6006	.8763
Planned SP type (%)
Relative	82.8	85.7	79.3	82.2	83.5	.6630	.8520
Friend	17.2	14.3	20.7	17.8	16.5
Importance of SP help (%)
Very	56.4	59.2	61.4	60.4	48.0	.1800	.2313
Somewhat	25.6	28.6	15.8	21.7	34.0
Not really	18.0	12.2	22.8	17.9	18.0
SP was helpful or bothersome
Bothersome	7.0	12.2	3.5	7.6	5.9	.2212	.2796
No effect	10.2	6.1	8.8	7.6	15.7
Helpful	82.8	81.6	87.7	84.8	78.4
CVD event score (mean [SD])^†	0.95 (1.47)	0.74 (1.21)	0.93 (1.63)	0.84 (1.45)	1.08 (1.50)	.3433	.1724
History of high BP (%)
Yes	86.9	84.0	89.7	87.0	86.7	.6843	1.0000
History of high cholesterol (%)
Yes	69.9	55.1	66.7	61.3	80.0	.0076	.0050
Current smoker (%)
Yes	15.6	16.0	8.6	12.0	19.8	.1861	.1698
Alcohol Use (%)
Current use	28.4	22.0	32.8	27.8	29.2	.2821	.6264
Never/past use	71.6	78.0	67.2	72.2	70.8

SBP (mean [SD])	140.3 (10.9)	142.7 (11.43)	140.2 (10.44)	141.3 (10.93)	139.0 (10.78)	.6771	.5433
Diastolic BP (mean [SD])	76.8 (9.00)	80.7 (8.26)	74.8 (9.20)	77.5 (9.23)	75.9 (8.68)	.1491	.4822
SF-36 physical subscale (mean [SD])	39.3 (11.16)	36.5 (11.30)	39.2 (11.65)	38.0 (11.51)	40.9 (10.55)	.1269	.0829
SF-36 mental subscale (mean [SD])	46.8 (11.94)	47.3 (12.75)	46.4 (12.03)	46.8 (12.31)	46.8 (11.54)	.9629	.9779
HbA1c (mean [SD])	7.6 (1.51)	7.5 (1.64)	7.5 (1.56)	7.5 (1.59)	7.6 (1.40)	.6860	.4102
Rating of personal doctor (mean [SD])	9.2 (1.07)	9.2 (1.05)	9.3 (0.97)	9.3 (1.00)	9.2 (1.14)	.8743	.6931
Rating of overall health care (mean [SD])	9.0 (1.33)	9.0 (1.55)	9.1 (1.11)	9.1 (1.32)	8.9 (1.37)	.6285	.3881
Perceived health competence (mean [SD])	3.2 (0.81)	3.3 (0.79)	3.3 (0.76)	3.3 (0.77)	3.2 (0.85)	.5539	.2278
Medication adherence (%)
High	40.4	50.0	29.8	39.3	41.8	.1584	.4358
Medium	51.5	42.0	63.2	53.3	49.5
Low	8.1	8.0	7.0	7.5	8.8
LDL cholesterol
N^‡	40	8	16	24	16	.3037	.9471
Mean (SD)	137.1 (23.77)	127.1 (25.31)	142.0 (22.32)	137.0 (23.90)	137.3 (24.35)

* N = 184–199; total sample = 199.
† CVD events score: 1 point each for past myocardial infarction, stroke, transient ischemic attack, coronary revascularization, and congestive heart failure.
‡ Number of participants in lipid measurement is only one fifth of total sample.
SP, support person; CVD, cardiovascular disease; BP, blood pressure; LDL, low-density lipoprotein.

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Table 4.

Support Person Characteristics

Age in Years (mean [SD])	55 (14.5)
Female (%)	75
Race (%)
White	86
African-American	13
Asian	1
Occupation status (%)
Employed	48
Retired	34
Unemployed	18
Education Level (%)
<High school	17
High school grad or GED	35
Some college	25
≥4-year degree	23
Relationship to patient (%)
Spouse	51
Child	16
Mother	5
Other relative	11
Friend and/or neighbor	17

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Table 5.

Primary Outcomes: Adjusted* and Unadjusted^† Group Differences at 6 Months and 9 to 12 Months After Baseline

	Baseline (mean [n])	6 Months (mean [n])	9 to 12 Months (mean [n])	Change from Baseline to 6 Months	Change from Baseline to 9 to 12 Months
Systolic BP (mmHg)
Intervention group AB	141.3 (108)	135.5 (92)	134.0 (81)	−5.8	−7.3
Control group C	139.0 (91)	133.6 (74)	133.8 (60)	−6.4	−5.2
Unadjusted P for AB vs C	.5433	.3836	.9427
Adjusted P for AB vs C	na	.4969	.6475
HbA1C (%)
Intervention group AB	7.5 (106)	8.3 (87)	7.4 (74)	0.8	−0.1
Control group C	7.6 (85)	7.8 (63)	7.4 (63)	0.2	−0.2
Unadjusted P for AB vs C	.4102	.0567	.6440
Adjusted P for AB vs C	na	.0429	.9164
SF-36 Physical composite score^‡
Intervention group AB	38.0 (107)	42.7 (84)	41.4 (74)	4.7	3.4
Control group C	40.9 (88)	42.6 (74)	41.6 (72)	1.7	0.7
Unadjusted P for AB vs C	.0829	.4145	.4345
Adjusted P for AB vs C	na	.9598	.9056
SF-36 mental composite score
Intervention group AB	46.8 (107)	42.7 (84)	45.7 (74)	−4.1	−1.1
Control group C	46.8 (88)	40.1 (74)	47.9 (72)	−6.7	1.1
Unadjusted P for AB vs C	.9779	.2666	.5200
Adjusted P for AB vs C	na	.2187	.2916
Rate of primary doctor^§
Intervention group AB	9.3 (98)		9.5 (71)		0.2
Control group C	9.2 (86)		9.3 (67)		0.1
Unadjusted P for AB vs C	.6931		.0255
Adjusted P for AB vs C	na		.6372
Rating of overall health care^§
Intervention group AB	9.3 (98)		8.3 (71)		−1.0
Control group C	9.2 (86)		8.5 (67)		−0.7
Unadjusted P for AB vs C	.6931		.0255
Adjusted P for AB vs C	na		.6709
LDL cholesterol^‖
Intervention group AB	137.0 (24)	139.4 (18)	135.4 (18)	2.4	−1.6
Control group C	137.3 (16)	130.5 (11)	110.6 (11)	−6.6	−26.7
Unadjusted P for AB vs C	.9471	.6716	.3238
Adjusted P for AB vs C

* Unadjusted: P adjusted only for clustering of patient within clinic and baseline outcome variable values for 6 months and 12 month comparisons.
† Adjusted: P adjusted for clustering, baseline outcome values, age, sex, race, education, employment status, health insurance, whether already had an SP, relationship with SP, baseline values for medication adherence, perceived health competence, patient self-report of history of high BP, history of high cholesterol, smoking status, alcohol use and history of cardiovascular events score (1 point each for previous myocardial infarction, stroke, transient ischemic attack, coronary revascularization, and congestive heart failure). Given the limited sample size for LDL measurements, no adjusted P are presented.
‡ SF-36 subscale possible range is 0–100.
§ Doctor and healthcare satisfaction scales each have possible range from 0–10.
‖ The smaller subsample of patients with measured LDL permitted analyses controlling only for baseline LDL and clustering within clinic, not for adjusted analyses with additional covariates.
BP, blood pressure; LDL, low-density lipoprotein, SP, support person.

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Table 6.

Minimum Detectable Between-Group Differences in Outcomes

Outcome	Detectable Difference at 6 mo	Detectable Difference at 9 to 12 mo
Systolic BP	10 mmHg	12 mmHg
LDL cholesterol	59 mg/dl	72 mg/dl
HbA1C (%)	1.3 percentage points	1.5 percentage points
SF-36 HRQL (100-pt scale)	6.5 points	6.9 points
Satisfaction with doctor (scale 0–10)	na	1.3 points
Satisfaction with healthcare (scale 0–10)	na	3.0 points