Trial Outcomes & Findings for BETTER HEALTH: Durham (NCT NCT03052959)
NCT ID: NCT03052959
Last Updated: 2021-11-01
Results Overview
The primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
Six months
Results posted on
2021-11-01
Participant Flow
Unit of analysis: Neighbourhoods
Participant milestones
| Measure |
Immediate Intervention
Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
|
Wait List Intervention
Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.
|
|---|---|---|
|
Overall Study
STARTED
|
59 5
|
66 5
|
|
Overall Study
COMPLETED
|
55 5
|
61 5
|
|
Overall Study
NOT COMPLETED
|
4 0
|
5 0
|
Reasons for withdrawal
| Measure |
Immediate Intervention
Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
|
Wait List Intervention
Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
Baseline Characteristics
BETTER HEALTH: Durham
Baseline characteristics by cohort
| Measure |
Immediate Intervention
n=59 Participants
Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
|
Wait List Intervention
n=66 Participants
Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six monthsThe primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.
Outcome measures
| Measure |
Immediate Intervention
n=59 Participants
Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
|
Wait List Intervention
n=66 Participants
Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
|
|---|---|---|
|
Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up
|
64.5 percent of actions
Standard Deviation 27.5
|
42.1 percent of actions
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: Six monthsThe investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline
Outcome measures
| Measure |
Immediate Intervention
n=59 Participants
Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
|
Wait List Intervention
n=66 Participants
Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
|
|---|---|---|
|
Completion of Individual Actions
Colorectal screening
|
14.3 percentage of eligible actions
|
0 percentage of eligible actions
|
|
Completion of Individual Actions
Cervical screening
|
25 percentage of eligible actions
|
11.1 percentage of eligible actions
|
|
Completion of Individual Actions
Body mass index screening
|
72.7 percentage of eligible actions
|
0 percentage of eligible actions
|
|
Completion of Individual Actions
Waist circumference
|
73.6 percentage of eligible actions
|
1.6 percentage of eligible actions
|
|
Completion of Individual Actions
Weight control
|
53.8 percentage of eligible actions
|
57.1 percentage of eligible actions
|
|
Completion of Individual Actions
Referral for body mass index greater than 25
|
76.9 percentage of eligible actions
|
46.9 percentage of eligible actions
|
|
Completion of Individual Actions
Smoking cessation
|
11.1 percentage of eligible actions
|
3.6 percentage of eligible actions
|
|
Completion of Individual Actions
Smoking cessation referral
|
59.3 percentage of eligible actions
|
32.1 percentage of eligible actions
|
|
Completion of Individual Actions
Alcohol control
|
66.7 percentage of eligible actions
|
52.4 percentage of eligible actions
|
|
Completion of Individual Actions
Alcohol cessation referral
|
40 percentage of eligible actions
|
9.5 percentage of eligible actions
|
|
Completion of Individual Actions
Physical activity improved
|
62.2 percentage of eligible actions
|
64.3 percentage of eligible actions
|
|
Completion of Individual Actions
Physical activity referral
|
71.1 percentage of eligible actions
|
41.1 percentage of eligible actions
|
|
Completion of Individual Actions
Healthy diet score improved
|
90.4 percentage of eligible actions
|
91.8 percentage of eligible actions
|
|
Completion of Individual Actions
Nutrition referral
|
67.3 percentage of eligible actions
|
29.5 percentage of eligible actions
|
|
Completion of Individual Actions
Fasting blood sugar/A1C screen
|
29.0 percentage of eligible actions
|
25.0 percentage of eligible actions
|
|
Completion of Individual Actions
Blood pressure screen
|
81.8 percentage of eligible actions
|
41.7 percentage of eligible actions
|
|
Completion of Individual Actions
Blood pressure monitor
|
66.7 percentage of eligible actions
|
66.7 percentage of eligible actions
|
|
Completion of Individual Actions
LDL measured
|
31.6 percentage of eligible actions
|
26.3 percentage of eligible actions
|
|
Completion of Individual Actions
Breast screening
|
50 percentage of eligible actions
|
0 percentage of eligible actions
|
SECONDARY outcome
Timeframe: Six monthsThe investigators will report the frequency with which self-referrals were reported to the prevention practitioner.
Outcome measures
| Measure |
Immediate Intervention
n=59 Participants
Immediate Intervention: The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
|
Wait List Intervention
n=66 Participants
Wait List Intervention: The control arm will receive the prevention practitioner intervention 6 months after the intervention arm.
|
|---|---|---|
|
Number of Self-referrals
Weight control
|
53.8 percentage of eligible actions
|
57.1 percentage of eligible actions
|
|
Number of Self-referrals
Referral for body mass index greater than 25
|
76.9 percentage of eligible actions
|
46.9 percentage of eligible actions
|
|
Number of Self-referrals
Smoking cessation referral
|
59.3 percentage of eligible actions
|
32.1 percentage of eligible actions
|
|
Number of Self-referrals
Alcohol cessation referral
|
40 percentage of eligible actions
|
9.5 percentage of eligible actions
|
|
Number of Self-referrals
Physical activity referral
|
71.1 percentage of eligible actions
|
41.1 percentage of eligible actions
|
|
Number of Self-referrals
Nutrition referral
|
67.3 percentage of eligible actions
|
29.5 percentage of eligible actions
|
|
Number of Self-referrals
Fasting blood sugar/A1C screen
|
29.0 percentage of eligible actions
|
25.0 percentage of eligible actions
|
|
Number of Self-referrals
Blood pressure screen
|
81.8 percentage of eligible actions
|
41.7 percentage of eligible actions
|
|
Number of Self-referrals
Blood pressure monitored
|
66.7 percentage of eligible actions
|
66.7 percentage of eligible actions
|
|
Number of Self-referrals
LDL measured
|
31.6 percentage of eligible actions
|
26.3 percentage of eligible actions
|
|
Number of Self-referrals
Breast cancer screening
|
50 percentage of eligible actions
|
0 percentage of eligible actions
|
|
Number of Self-referrals
Colorectal cancer screening
|
14.3 percentage of eligible actions
|
0 percentage of eligible actions
|
|
Number of Self-referrals
Cervical screening
|
25.0 percentage of eligible actions
|
11.1 percentage of eligible actions
|
Adverse Events
Immediate Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place