J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website https://jocmr.elmerjournals.com

Original Article

Volume 17, Number 5, May 2025, pages 247-255

Does Receiving Information on Clinical Trials Affect Patients’ Condition?

**Table 1.** Patient Characteristics
Characteristic	Overall (N = 21)	R-HT (N = 7)	Diabetic neuropathy (N = 14)
DBP: diastolic blood pressure; EDOs: early dropouts; eGFR: estimated glomerular filtration rate; HbA1c: hemoglobin A1c; PRTs: patients randomized to treatment; R-HT: treatment-resistant hypertension; SBP: systolic blood pressure; SD: standard deviation; UACR: urine albumin-creatinine ratio.
Sex, n (%)
Male	17 (81.0%)	4 (57.1%)	13 (92.9%)
Female	4 (19.0%)	3 (42.9%)	1 (7.1%)
Age, mean (SD)	60.7 (12.0)	53.7 (12.4)	64.2 (10.5)
Entry, n (%)
EDOs	6 (28.6%)	4 (57.1%)	2 (14.3%)
PRTs	15 (71.4%)	3 (42.9%)	12 (85.7%)
SBP, mean (SD)
Before explanation	150.0 (24.6)	173.4 (13.9)	138.2 (19.9)
After explanation	142.9 (19.9)	152.4 (19.0)	138.1 (19.2)
DBP, mean (SD)
Before explanation	85.1 (18.5)	99.0 (16.1)	78.1 (15.8)
After explanation	81.9 (16.2)	86.4 (20.5)	79.6 (13.8)
HbA1c, mean (SD)
Before explanation	7.6 (1.7)	5.6 (0.6)	8.3 (1.3)
Missing	2	2	0
After explanation	7.7 (1.7)	5.8 (0.4)	8.4 (1.4)
Missing	2	2	0
eGFR, mean (SD)
Before explanation	56.9 (25.0)	70.0 (18.3)	51.3 (26.0)
Missing	1	1	0
After explanation	59.8 (29.0)	75.7 (20.2)	53.0 (30.1)
Missing	1	1	0
K, mean (SD)
Before explanation	4.35 (0.41)	-	4.35 (0.41)
Missing	7	7	0
After explanation	4.34 (0.43)	-	4.34 (0.43)
Missing	7	7	7
UACR, mean (SD)
Before explanation	1,790 (2,056)	-	1,790 (2,056)
Missing	14	7	7
After explanation	856.2 (1,045)	-	856.2 (1,045)
Missing	14	7	7

Table 1. Patient Characteristics

Characteristic

Overall (N = 21)

R-HT (N = 7)

Diabetic neuropathy (N = 14)

DBP: diastolic blood pressure; EDOs: early dropouts; eGFR: estimated glomerular filtration rate; HbA1c: hemoglobin A1c; PRTs: patients randomized to treatment; R-HT: treatment-resistant hypertension; SBP: systolic blood pressure; SD: standard deviation; UACR: urine albumin-creatinine ratio.

Sex, n (%)

Male

17 (81.0%)

4 (57.1%)

13 (92.9%)

Female

4 (19.0%)

3 (42.9%)

1 (7.1%)

Age, mean (SD)

60.7 (12.0)

53.7 (12.4)

64.2 (10.5)

Entry, n (%)

EDOs

6 (28.6%)

4 (57.1%)

2 (14.3%)

PRTs

15 (71.4%)

3 (42.9%)

12 (85.7%)

SBP, mean (SD)

Before explanation

150.0 (24.6)

173.4 (13.9)

138.2 (19.9)

After explanation

142.9 (19.9)

152.4 (19.0)

138.1 (19.2)

DBP, mean (SD)

Before explanation

85.1 (18.5)

99.0 (16.1)

78.1 (15.8)

After explanation

81.9 (16.2)

86.4 (20.5)

79.6 (13.8)

HbA1c, mean (SD)

Before explanation

7.6 (1.7)

5.6 (0.6)

8.3 (1.3)

Missing

After explanation

7.7 (1.7)

5.8 (0.4)

8.4 (1.4)

Missing

eGFR, mean (SD)

Before explanation

56.9 (25.0)

70.0 (18.3)

51.3 (26.0)

Missing

After explanation

59.8 (29.0)

75.7 (20.2)

53.0 (30.1)

Missing

K, mean (SD)

Before explanation

4.35 (0.41)

Missing

After explanation

4.34 (0.43)

Missing

UACR, mean (SD)

Before explanation

1,790 (2,056)

Missing

After explanation

856.2 (1,045)

Missing

**Table 2.** Changes in Variables From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on R-HT or Diabetic Nephropathy
	n	Geometric mean	Coefficient of variation	Geometric mean of rate of change (after/before)	95% CI	P value
BP was measured on the ipsilateral arm with the patient in a sitting position using a validated automated device (OMRON HEM-907; Omron Healthcare Corp., Kyoto, Japan). Before the explanation of the clinical trial, BP was measured once by the attending physician. After explanation, BP was measured two or three times at 1-min intervals by the CRC or nurse and the average was calculated. Early dropouts were patients who became ineligible to participate in the clinical trial after receiving an explanation of the study but before providing informed consent and patients who dropped out during the pre-randomization observation period after providing informed consent, and patients randomized to treatment were patients who provided informed consent and were randomized. We calculated the geometric mean value and coefficient of variation of the parameters and rate of change related to the participation criteria before and after explanation of the two trials. We also calculated the geometric mean value and 95% CI of the rate of change for each participant. The test values before and after explanation were logarithmically transformed, and the changes were evaluated with a paired t-test. Cases with missing data were excluded from the analysis. CI: confidence interval; DBP: diastolic blood pressure; eGFR: estimated glomerular filtration rate; HbA1c: hemoglobin A1c; K: potassium; R-HT: treatment-resistant hypertension; SBP: systolic blood pressure; UACR: urine albumin-creatinine ratio.
SBP, mm Hg
Before explanation	21	148	0.164	0.955	0.862 - 1.059	0.3747
After explanation	21	141.4	0.139
DBP, mm Hg
Before explanation	21	83.1	0.217	0.965	0.840 - 1.107	0.6001
After explanation	21	80.2	0.198
HbA1c, %
Before explanation	19	7.4	0.22	1.007	0.879 - 1.170	0.8432
After explanation	19	7.5	0.22
eGFR, mL/min/1.73 m²
Before explanation	20	52.1	0.44	1.007	0.766 - 1.381	0.8492
After explanation	20	53.5	0.486
K, mmol/L
Before explanation	14	4.33	0.094	0.999	0.927 - 1.075	0.9609
After explanation	14	4.32	0.099
UACR, mg/g
Before explanation	7	900	1.149	0.898	0.115 - 2.175	0.3241
After explanation	7	450	1.22

Table 2. Changes in Variables From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on R-HT or Diabetic Nephropathy

Geometric mean

Coefficient of variation

Geometric mean of rate of change (after/before)

95% CI

P value

BP was measured on the ipsilateral arm with the patient in a sitting position using a validated automated device (OMRON HEM-907; Omron Healthcare Corp., Kyoto, Japan). Before the explanation of the clinical trial, BP was measured once by the attending physician. After explanation, BP was measured two or three times at 1-min intervals by the CRC or nurse and the average was calculated. Early dropouts were patients who became ineligible to participate in the clinical trial after receiving an explanation of the study but before providing informed consent and patients who dropped out during the pre-randomization observation period after providing informed consent, and patients randomized to treatment were patients who provided informed consent and were randomized. We calculated the geometric mean value and coefficient of variation of the parameters and rate of change related to the participation criteria before and after explanation of the two trials. We also calculated the geometric mean value and 95% CI of the rate of change for each participant. The test values before and after explanation were logarithmically transformed, and the changes were evaluated with a paired t-test. Cases with missing data were excluded from the analysis. CI: confidence interval; DBP: diastolic blood pressure; eGFR: estimated glomerular filtration rate; HbA1c: hemoglobin A1c; K: potassium; R-HT: treatment-resistant hypertension; SBP: systolic blood pressure; UACR: urine albumin-creatinine ratio.

SBP, mm Hg

Before explanation

148

0.164

0.955

0.862 - 1.059

0.3747

After explanation

141.4

0.139

DBP, mm Hg

Before explanation

83.1

0.217

0.965

0.840 - 1.107

0.6001

After explanation

80.2

0.198

HbA1c, %

Before explanation

7.4

0.22

1.007

0.879 - 1.170

0.8432

After explanation

7.5

0.22

eGFR, mL/min/1.73 m²

Before explanation

52.1

0.44

1.007

0.766 - 1.381

0.8492

After explanation

53.5

0.486

K, mmol/L

Before explanation

4.33

0.094

0.999

0.927 - 1.075

0.9609

After explanation

4.32

0.099

UACR, mg/g

Before explanation

900

1.149

0.898

0.115 - 2.175

0.3241

After explanation

450

1.22

**Table 3.** Changes in Blood Pressure From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on R-HT or Diabetic Nephropathy
	Both clinical trials	Trial on resistant hypertension	Trial on diabetic nephropathy
*P < 0.05. The 95% CI was calculated for the difference in variables. Differences in variables before and after explanation of one of the trials were evaluated with a paired t-test. Cases with missing data were excluded from the analysis. CI: confidence interval; DBP: diastolic blood pressure; R-HT: treatment-resistant hypertension; SBP: systolic blood pressure.
SBP before explanation	149.95	7.05	2.51 - 16.61	0.140	173.43	21.00	0.77 - 41.23	0.044*	138.21	0.071	9.94 - 10.08	0.988
SBP after explanation	142.90				152.43				138.14
DBP before explanation	85.10	3.24	2.35 - 8.82	0.241	99.00	12.57	0.23 - 24.91	0.047*	78.14	-1.43	6.57 - 3.71	0.558
DBP after explanation	81.86				86.43				79.57

Table 3. Changes in Blood Pressure From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on R-HT or Diabetic Nephropathy

Both clinical trials

Trial on resistant hypertension

Trial on diabetic nephropathy

N = 21

Difference

95% CI

P value

n = 7

Difference

95% CI

P value

n = 14

Difference

95% CI

P value

*P < 0.05. The 95% CI was calculated for the difference in variables. Differences in variables before and after explanation of one of the trials were evaluated with a paired t-test. Cases with missing data were excluded from the analysis. CI: confidence interval; DBP: diastolic blood pressure; R-HT: treatment-resistant hypertension; SBP: systolic blood pressure.

SBP before explanation

149.95

7.05

2.51 - 16.61

0.140

173.43

21.00

0.77 - 41.23

0.044*

138.21

0.071

9.94 - 10.08

0.988

SBP after explanation

142.90

152.43

138.14

DBP before explanation

85.10

3.24

2.35 - 8.82

0.241

99.00

12.57

0.23 - 24.91

0.047*

78.14

-1.43

6.57 - 3.71

0.558

DBP after explanation

81.86

86.43

79.57

**Table 4.** Rate of Change in Variables Related to Participation Criteria for EDOs and PRTs
Variable	EDOs	PRTs	Geometric mean ratio (PRTs/EDOs)	95% CI	P value
The geometric mean and coefficient of variation of rate of change were calculated. Rates of change were compared by a covariance analysis model with the logarithmically transformed rate of change as the response variable and the logarithmically transformed baseline value as the explanatory variable. From the results of the covariance analysis, we calculated the geometric mean ratio and 95% CI of the rate of change adjusted by the baseline value. CI: confidence interval; DBP: diastolic blood pressure; EDOs: early dropouts; eGFR: estimated glomerular filtration rate; HbA1c: hemoglobin A1c; K: potassium; PRTs: patients randomized to treatment; SBP: systolic blood pressure; UACR: urine albumin-creatinine ratio.
SBP	6	0.894	0.163	15	0.981	0.124	1.065	0.935 - 1.213	0.3226
DBP	6	0.944	0.158	15	0.973	0.150	1.016	0.875 - 1.179	0.8285
HbA1c	4	1.014	0.046	15	1.014	0.059	1.005	0.940 - 1.075	0.8730
eGFR	5	0.999	0.053	15	1.038	0.108	1.011	0.913 - 1.121	0.8205
K	2	1.073	0.100	12	0.986	0.142	0.894	0.763 - 1.046	0.1451
UACR	1	0.415	-	6	0.516	0.471	0.679	0.044 - 10.5	0.7150

Table 4. Rate of Change in Variables Related to Participation Criteria for EDOs and PRTs

Variable

EDOs

PRTs

Geometric mean ratio (PRTs/EDOs)

95% CI

P value

Geometric mean of rate of change

Coefficient of variation

Geometric mean of rate of change

Coefficient of variation

The geometric mean and coefficient of variation of rate of change were calculated. Rates of change were compared by a covariance analysis model with the logarithmically transformed rate of change as the response variable and the logarithmically transformed baseline value as the explanatory variable. From the results of the covariance analysis, we calculated the geometric mean ratio and 95% CI of the rate of change adjusted by the baseline value. CI: confidence interval; DBP: diastolic blood pressure; EDOs: early dropouts; eGFR: estimated glomerular filtration rate; HbA1c: hemoglobin A1c; K: potassium; PRTs: patients randomized to treatment; SBP: systolic blood pressure; UACR: urine albumin-creatinine ratio.

SBP

0.894

0.163

0.981

0.124

1.065

0.935 - 1.213

0.3226

DBP

0.944

0.158

0.973

0.150

1.016

0.875 - 1.179

0.8285

HbA1c

1.014

0.046

1.014

0.059

1.005

0.940 - 1.075

0.8730

eGFR

0.999

0.053

1.038

0.108

1.011

0.913 - 1.121

0.8205

1.073

0.100

0.986

0.142

0.894

0.763 - 1.046

0.1451

UACR

0.415

0.516

0.471

0.679

0.044 - 10.5

0.7150

**Table 5.** Changes From Before to After Receiving the Explanation of the Clinical Trial in the Type of Guidance Given by Medical Staff and the Implementation of Guidance by Patients
Type of guidance given by medical staff	Before receiving explanation	After providing informed consent
Patients received information about a double-blind clinical trial on treatment-resistant hypertension or one on diabetic nephropathy. Data are shown for patients who dropped out after providing informed consent and those who were randomized to treatment. ^aRatio of the number of people who put the guidance into practice to the number of people who received guidance.
Dietary guidance	17	81.0	8	47.1	16	76.2	10	62.5
Salt reduction guidance	12	57.1	4	33.3	9	42.9	3	33.3
Exercise guidance	15	71.4	7	46.7	13	61.9	9	69.2
Smoking cessation guidance	5	23.8	3	60.0	4	19.0	2	50.0
Guidance on alcohol consumption	5	23.8	2	40.0	5	23.8	3	60.0
Did not receive any guidance	0	0.0	-	-	2	9.5	-	-

Table 5. Changes From Before to After Receiving the Explanation of the Clinical Trial in the Type of Guidance Given by Medical Staff and the Implementation of Guidance by Patients

Type of guidance given by medical staff

Before receiving explanation

After providing informed consent

Received guidance, n

Put into practice, n

%^a

Received guidance, n

Put into practice, n

%^a

Patients received information about a double-blind clinical trial on treatment-resistant hypertension or one on diabetic nephropathy. Data are shown for patients who dropped out after providing informed consent and those who were randomized to treatment. ^aRatio of the number of people who put the guidance into practice to the number of people who received guidance.

Dietary guidance

81.0

47.1

76.2

62.5

Salt reduction guidance

57.1

33.3

42.9

33.3

Exercise guidance

71.4

46.7

61.9

69.2

Smoking cessation guidance

23.8

60.0

19.0

50.0

Guidance on alcohol consumption

23.8

40.0

23.8

60.0

Did not receive any guidance

0.0

9.5

**Table 6.** Changes in the Number of Patients Ranking Expectations as First, Second, or Third Most Important From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on Treatment-Resistant Hypertension or Diabetic Nephropathy
Expectations	Number of patients ranking expectation as first, second, or third before receiving explanation	Number of patients ranking expectation as first, second, or third after providing informed consent
Data are shown for patients who dropped out after providing informed consent and those who were randomized to treatment. CRC: clinical research coordinator.
Trial treatment may be effective	11	2	1	7	3	1
Will receive a detailed medical examination	3	8	1	5	7	2
Will take a proactive approach to the disease	1	3	1	2	3	3
Will feel safe because CRC will always follow the patient	2	0	4	2	3	2
Medical costs will be low	3	2	0	4	1	2
Will receive burden relief compensation	0	2	1	0	2	1
Will contribute to the development of new treatments	1	3	3	0	1	4
No particular expectations	0	0	0	0	0	0

Table 6. Changes in the Number of Patients Ranking Expectations as First, Second, or Third Most Important From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on Treatment-Resistant Hypertension or Diabetic Nephropathy

Expectations

Number of patients ranking expectation as first, second, or third before receiving explanation

Number of patients ranking expectation as first, second, or third after providing informed consent

First

Second

Third

First

Second

Third

Data are shown for patients who dropped out after providing informed consent and those who were randomized to treatment. CRC: clinical research coordinator.

Trial treatment may be effective

Will receive a detailed medical examination

Will take a proactive approach to the disease

Will feel safe because CRC will always follow the patient

Medical costs will be low

Will receive burden relief compensation

Will contribute to the development of new treatments

No particular expectations

**Table 7.** Change in the Number of Patients Ranking Anxieties as First, Second, or Third Most Important From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on Treatment-Resistant Hypertension or Diabetic Nephropathy
Patient concerns	Number of patients ranking expectation as first, second, or third before receiving explanation	Number of patients ranking expectation as first, second, or third after providing informed consent
Data are shown for patients who dropped out after providing informed consent and those who were randomized to treatment. The table shows the changes in the number of patients ranking the concerns as the first, second, or third most important. Before the clinical trial, patients were most concerned about side effects, but once they had provided informed consent, the percentage of worries decreased significantly.
Worried about side effects	4	1	0	1	0	0
Time constraints for visiting the hospital will be troublesome	0	1	0	0	0	0
Anxiety about effectiveness	0	1	1	0	2	0
Worried about enrollment as the placebo/sham group	0	0	1	1	0	1
Dissatisfied with the response of medical staff	0	0	0	0	0	0
Wish to continue the same treatment even after the trial ended	1	0	0	1	0	0
Medical costs did not come down as much as expected	1	0	0	1	0	0
No particular concerns or complaints	14	0	0	16	0	0

Table 7. Change in the Number of Patients Ranking Anxieties as First, Second, or Third Most Important From Before to After Receiving an Explanation of a Double-Blind Randomized Clinical Trial on Treatment-Resistant Hypertension or Diabetic Nephropathy

Patient concerns

Number of patients ranking expectation as first, second, or third before receiving explanation

Number of patients ranking expectation as first, second, or third after providing informed consent

First

Second

Third

First

Second

Third

Data are shown for patients who dropped out after providing informed consent and those who were randomized to treatment. The table shows the changes in the number of patients ranking the concerns as the first, second, or third most important. Before the clinical trial, patients were most concerned about side effects, but once they had provided informed consent, the percentage of worries decreased significantly.

Worried about side effects

Time constraints for visiting the hospital will be troublesome

Anxiety about effectiveness

Worried about enrollment as the placebo/sham group

Dissatisfied with the response of medical staff

Wish to continue the same treatment even after the trial ended

Medical costs did not come down as much as expected

No particular concerns or complaints

**Table 8.** Comparison of Changes in Health-Related Behavior in Patients Who Received an Explanation of a Double-Blind Randomized Clinical Trial on Treatment-Resistant Hypertension or Diabetic Nephropathy
Change in health-related behavior	n	%	Early dropouts	Patients randomized to treatment
Early dropouts were patients who became ineligible to participate in the clinical trial after receiving an explanation of the study but before providing informed consent and patients who dropped out during the pre-randomization observation period after providing informed consent, and patients randomized to treatment were patients who provided informed consent and were randomized.
Became more proactive than only during treatment	8	38.1	4	4
Became more involved than only during treatment	8	38.1	0	8
No change	5	23.8	2	3
Became passive	0	0.0	0	0

Table 8. Comparison of Changes in Health-Related Behavior in Patients Who Received an Explanation of a Double-Blind Randomized Clinical Trial on Treatment-Resistant Hypertension or Diabetic Nephropathy

Change in health-related behavior

Early dropouts

Patients randomized to treatment

Early dropouts were patients who became ineligible to participate in the clinical trial after receiving an explanation of the study but before providing informed consent and patients who dropped out during the pre-randomization observation period after providing informed consent, and patients randomized to treatment were patients who provided informed consent and were randomized.

Became more proactive than only during treatment

38.1

Became more involved than only during treatment

38.1

No change

23.8

Became passive

0.0