Trial Outcomes & Findings for Reducing Risk of Recurrence (NCT NCT01122394)

NCT ID: NCT01122394

Last Updated: 2016-10-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 140 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-10-20

Participant Flow

Participants were recruited from a prior American Heart Association-funded study testing the effectiveness of a 6-mo TI vs. AP. Participants were recruited at completion of the AHA study to participate in the current study for an additional 6 months. They continued to receive the intervention to which they were originally assigned in the AHA study.

Participant milestones

Measure	Tailored Intervention (TI) Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Overall Study STARTED	66	74
Overall Study COMPLETED	63	70
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Tailored Intervention (TI) Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	2	2
Overall Study Adverse Event	0	1

Baseline Characteristics

Reducing Risk of Recurrence

Baseline characteristics by cohort

Measure	Tailored Intervention (TI) n=66 Participants Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=74 Participants General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)	Total n=140 Participants Total of all reporting groups
Age, Continuous	66.38 years STANDARD_DEVIATION 9.86 • n=5 Participants	68.73 years STANDARD_DEVIATION 10.30 • n=7 Participants	67.62 years STANDARD_DEVIATION 10.13 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	74 Participants n=7 Participants	138 Participants n=5 Participants
Race/Ethnicity, Customized White (non-Hispanic)	21 participants n=5 Participants	27 participants n=7 Participants	48 participants n=5 Participants
Race/Ethnicity, Customized Black/African American (non-Hispanic)	35 participants n=5 Participants	34 participants n=7 Participants	69 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Refused	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment

Outcome measures

Measure	Tailored Intervention (TI) n=54 Participants Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=59 Participants General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Systolic Blood Pressure	130.83 mm Hg Interval 119.5 to 144.83	133.67 mm Hg Interval 114.5 to 144.0

SECONDARY outcome

Timeframe: 6 months

self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)

Outcome measures

Measure	Tailored Intervention (TI) n=63 Participants Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=70 Participants General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Dietary Sodium pre-action	11 participants	18 participants
Dietary Sodium Action or Maintenance	52 participants	52 participants

SECONDARY outcome

Timeframe: 6 months

Population: Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis

Outcome measures

Measure	Tailored Intervention (TI) n=60 Participants Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=71 Participants General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Total Cholesterol/High Density Lipoprotein Ratio	3.47 ratio Interval 2.8 to 4.25	3.21 ratio Interval 2.8 to 3.81

SECONDARY outcome

Timeframe: 6 months

Measured by 7-day Physical Activity Recall

Outcome measures

Measure	Tailored Intervention (TI) n=63 Participants Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=70 Participants General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Exercise Adherence	2.50 hours per week of cardio Interval 1.25 to 5.25	2.75 hours per week of cardio Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: 6 months

Population: One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis

Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent

Outcome measures

Measure	Tailored Intervention (TI) n=62 Participants Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=70 Participants General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Antihypertensive/ Lipid-lowering Medication Adherence	3.58 units on a scale Standard Deviation 0.76	3.43 units on a scale Standard Deviation 0.79

Adverse Events

Tailored Intervention (TI)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Attention Placebo (AP)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tailored Intervention (TI) n=66 participants at risk Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=74 participants at risk General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Nervous system disorders Stroke	0.00% 0/66	1.4% 1/74
Cardiac disorders Coronary Artery Bypass Graft	1.5% 1/66	1.4% 1/74

Other adverse events

Measure	Tailored Intervention (TI) n=66 participants at risk Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model	Attention Placebo (AP) n=74 participants at risk General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
Musculoskeletal and connective tissue disorders Broken bone	3.0% 2/66	2.7% 2/74
Musculoskeletal and connective tissue disorders Torn Ligament	1.5% 1/66	1.4% 1/74
Musculoskeletal and connective tissue disorders Bone/Muscle injury	9.1% 6/66	8.1% 6/74

Additional Information

Jennifer Friedberg, Ph.D.

VA New York Harbor Healthcare System

Phone: 212-951-3314

Email: jennifer.friedberg@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place