Trial Outcomes & Findings for Advance Planning for Home Services for Seniors (NCT NCT02256072)
NCT ID: NCT02256072
Last Updated: 2017-04-14
Results Overview
The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the "Planning Implementation (Behavior)" assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
385 participants
Primary outcome timeframe
baseline and 1 month
Results posted on
2017-04-14
Participant Flow
Recruitment for this study took place between October 1, 2014 and September 30, 2015.
Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach ). All participants reached randomization.
Participant milestones
| Measure |
Plan Your Lifespan Website
Participants in the intervention arm will navigate PlanYourLifespan.org.
|
Go4Life Website
Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
191
|
|
Overall Study
Completed 1 Month Follow-Up
|
167
|
179
|
|
Overall Study
COMPLETED
|
152
|
162
|
|
Overall Study
NOT COMPLETED
|
42
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Advance Planning for Home Services for Seniors
Baseline characteristics by cohort
| Measure |
Plan Your Lifespan Website
n=194 Participants
Participants in the intervention arm will navigate Planyourlifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte
|
Go4Life Website
n=191 Participants
Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.67 years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
72.05 years
STANDARD_DEVIATION 5.57 • n=7 Participants
|
71.86 years
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
117 participants
n=5 Participants
|
125 participants
n=7 Participants
|
242 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
55 participants
n=5 Participants
|
38 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
9 participants
n=5 Participants
|
14 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Marital Status
Single, never married
|
23 participants
n=5 Participants
|
27 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Marital Status
Married
|
85 participants
n=5 Participants
|
75 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Marital Status
Widowed
|
36 participants
n=5 Participants
|
44 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Marital Status
Divorced/Separated
|
50 participants
n=5 Participants
|
45 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Education
High school or less
|
40 participants
n=5 Participants
|
33 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Education
Some college
|
59 participants
n=5 Participants
|
55 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Education
College graduate
|
95 participants
n=5 Participants
|
103 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Household Income
less than $20,000
|
43 participants
n=5 Participants
|
45 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Household Income
$20,000-$40,000
|
54 participants
n=5 Participants
|
50 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Household Income
$40,001-$60,000
|
27 participants
n=5 Participants
|
31 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Household Income
$60,001-$80,000
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Household Income
$80,001-$100,000
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Household Income
More than $100,000
|
18 participants
n=5 Participants
|
13 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Household Income
Not Sure/Don't Know
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Household Income
Prefer not to say
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Self-Reported Health Rating
Poor
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Self-Reported Health Rating
Fair
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Self-Reported Health Rating
Good
|
81 participants
n=5 Participants
|
76 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Self-Reported Health Rating
Very Good
|
70 participants
n=5 Participants
|
62 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
Self-Reported Health Rating
Excellent
|
21 participants
n=5 Participants
|
27 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Living Arrangement
Live alone
|
94 participants
n=5 Participants
|
104 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Living Arrangement
Live with one other person
|
90 participants
n=5 Participants
|
75 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
Living Arrangement
Live with multiple people (more than one)
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
REALM-R
Low Literacy
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
REALM-R
Marginal Literacy
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
REALM-R
Adequate Literacy
|
165 participants
n=5 Participants
|
159 participants
n=7 Participants
|
324 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 monthPopulation: All randomized participants with a complete planning behavior score at baseline and one-month.
The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the "Planning Implementation (Behavior)" assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.
Outcome measures
| Measure |
Plan Your Lifespan Website
n=167 Participants
Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte
|
Go4Life Website
n=179 Participants
Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
|
|---|---|---|
|
Planning Behavior Score at 1-month
Baseline Planning Behavior Score
|
16.97 units on a scale
Standard Deviation 4.38
|
16.80 units on a scale
Standard Deviation 4.58
|
|
Planning Behavior Score at 1-month
One Month Planning Behavior Score
|
17.19 units on a scale
Standard Deviation 4.48
|
15.88 units on a scale
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1 month, and 3 monthsPopulation: Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.
Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the "Planning Perception" assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months.
Outcome measures
| Measure |
Plan Your Lifespan Website
n=179 Participants
Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte
|
Go4Life Website
n=183 Participants
Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
|
|---|---|---|
|
Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months
Baseline Planning Perception Score
|
19.75 units on a scale
Standard Deviation 4.02
|
20.11 units on a scale
Standard Deviation 3.64
|
|
Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months
Post-Tool Planning Perception Score
|
20.70 units on a scale
Standard Deviation 3.85
|
20.01 units on a scale
Standard Deviation 3.74
|
|
Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months
One-Month Planning Perception Score
|
20.75 units on a scale
Standard Deviation 3.69
|
20.29 units on a scale
Standard Deviation 3.61
|
|
Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months
Three-Month Planning Perception Score
|
21.14 units on a scale
Standard Deviation 3.55
|
20.81 units on a scale
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1 month, and 3 monthsPopulation: Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.
Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.
Outcome measures
| Measure |
Plan Your Lifespan Website
n=179 Participants
Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte
|
Go4Life Website
n=183 Participants
Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
|
|---|---|---|
|
Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months
Baseline CAHS Score
|
20.85 units on a scale
Standard Deviation 3.29
|
20.70 units on a scale
Standard Deviation 3.45
|
|
Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months
Post-Tool CAHS Score
|
21.39 units on a scale
Standard Deviation 2.89
|
20.67 units on a scale
Standard Deviation 3.37
|
|
Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months
One-Month CAHS Score
|
21.74 units on a scale
Standard Deviation 2.62
|
21.19 units on a scale
Standard Deviation 2.93
|
|
Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months
Three-Month CAHS Score
|
22.17 units on a scale
Standard Deviation 2.33
|
21.70 units on a scale
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1 month, and 3 monthsPopulation: Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.
Knowledge of home services score at all follow-up time points as measured by "Understanding of Home Services" assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.
Outcome measures
| Measure |
Plan Your Lifespan Website
n=179 Participants
Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte
|
Go4Life Website
n=183 Participants
Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.
Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
|
|---|---|---|
|
Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months
Baseline UHS Score
|
3.56 units on a scale
Standard Deviation 1.28
|
3.79 units on a scale
Standard Deviation 1.27
|
|
Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months
Post-Tool UHS Score
|
4.12 units on a scale
Standard Deviation 1.26
|
3.93 units on a scale
Standard Deviation 1.21
|
|
Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months
One-Month UHS Score
|
4.10 units on a scale
Standard Deviation 1.35
|
3.72 units on a scale
Standard Deviation 1.39
|
|
Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months
Three-Month UHS Score
|
4.18 units on a scale
Standard Deviation 1.45
|
3.73 units on a scale
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1 month, and 3 monthsPopulation: Due to errors in the data collection method, it is not possible to summarize the data for reporting.
Overall satisfaction with the intervention or attention control as measured by the "Satisfaction with Intervention Tool." Tests will be performed at a two-sided 5% significance level.
Outcome measures
Outcome data not reported
Adverse Events
Plan Your Lifespan Website
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Go4Life Website
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
Dr. Lee A. Lindquist
Northwestern University Feinberg School of Medicine
Phone: 312-503-3916
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place