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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The goal of this study is to develop and test an advance planning tool to help seniors understand projected health needs and plan ways to remain in their own homes when these crises occur. In this phase of the study through partnerships with seniors, senior community groups, area agencies on aging, and home care agencies the investigators are conducting a two-armed (attention control and intervention) randomized controlled trial.
Individuals will be randomly assigned to one of two interventions: attention control or the advance planning tool. The investigators 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. Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Web site 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 Web site. The Web site is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
If randomized to intervention, subjects will be introduced to the advance planning tool, the Plan Your Lifespan website, and given instructions on how to use it. Plan Your Lifespan is 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 website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making. Participants will navigate and complete the Web-based advance planning tool and will be allotted a minimum of 15 minutes and a maximum of 45 minutes to navigate the tool as part of the study.
All participants will be administered a pre- and post-test before and after viewing the website they were randomized to. All participants will be followed up at one and three months post via a brief phone call where follow-up questions will be asked of all participants.
Seniors over the age of 65 years represent 13.1% of the United States population, with a projected 36% increase to 55 million by the year 2020. With advancing age, seniors experience an increased prevalence in memory loss, physical disability, and multiple chronic conditions (e.g., heart disease, emphysema, stroke, diabetes, cancers, hypertension, arthritis, osteoporosis, and macular degeneration). A large fear among seniors is loss of independence and removal from their homes to be placed in a nursing home. Seniors who remain in their own homes tend to have greater satisfaction, less depression, and maintain their physical function better than seniors residing in assisted living or nursing homes. Although remaining in the home is of utmost importance, many frail seniors teeter between safe living and personal endangerment. Falls, illness, and worsening memory all jeopardize a senior's independence and ability to remain in his or her home.
The advance planning tool, Plan Your Lifespan, provides information that will help older Americans to "fill in the gaps" in their lives as necessary. An established plan would offer guidance toward obtaining those resources and professional services that would be useful to the senior. An effective plan would be dynamic and adaptable to the senior's changing health needs.
The aim of this study is to conduct a randomized controlled trial of the advance planning tool to determine subject understanding of home care services, advanced health planning, and other patient-centered outcomes. The investigators also hypothesize the following:
H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the advance planning tool will show increased planning with regard to implementation/behavior, perception, and intention (measured via the Planning Assessment tool) one month after intervention.
H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the advance planning tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one month after intervention.
H3: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the advance planning tool will show increased understanding of home services (measured via the Understanding of Home Services tool) one month after intervention.
H4: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the advance planning tool will be more likely to report communicating their preferences about issues related to lifespan planning to people who may need to make decisions for them (measured via the Communication about Lifespan Planning Questionnaire) after study intervention.
H5: Compared to participants in the attention control group, participants randomized to the advance planning tool will report overall satisfaction with the intervention/attention control (measured via the Satisfaction with Intervention tool).
The total duration of the intervention for each participant will be three months with assessments at baseline, post-intervention, and two follow-up assessments at one and three months for a total of 4 data collection points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plan Your Lifespan Website | Experimental | Participants in the intervention arm will navigate the Plan Your Lifespan website, 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. |
|
| Go4Life Website | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plan Your Lifespan Website | Other | 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 interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making. |
| Measure | Description | Time Frame |
|---|---|---|
| Planning Behavior Score at 1-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%. | baseline and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months | 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. | baseline, post-intervention, 1 month, and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee A Lindquist, MD, MPH, MBA | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Aging & In-Home Services of Northeast Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29091979 | Derived | Lindquist LA, Ramirez-Zohfeld V, Sunkara PD, Forcucci C, Campbell DS, Mitzen P, Ciolino JD, Kricke G, Seltzer A, Ramirez AV, Cameron KA. Helping Seniors Plan for Posthospital Discharge Needs Before a Hospitalization Occurs: Results from the Randomized Control Trial of PlanYourLifespan.org. J Hosp Med. 2017 Nov;12(11):911-917. doi: 10.12788/jhm.2798. Epub 2017 Aug 23. |
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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.
Recruitment for this study took place between October 1, 2014 and September 30, 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Plan Your Lifespan Website | Participants in the intervention arm will navigate PlanYourLifespan.org. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plan Your Lifespan Website | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Planning Behavior Score at 1-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%. | All randomized participants with a complete planning behavior score at baseline and one-month. | Posted | Mean | Standard Deviation | units on a scale | baseline and 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plan Your Lifespan Website | 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. PlanYourLifespan.org is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making. PlanYourLifespan.org: Participants in the intervention arm will navigate PlanYourLifespan.org, 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee A. Lindquist | Northwestern University Feinberg School of Medicine | 312-503-3916 | LAL425@md.northwestern.edu |
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|
| Go4Life Website | Other | 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 | 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. | baseline, post-intervention, 1 month, and 3 months |
| Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months | 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. | baseline, post-intervention, 1 month, and 3 months |
| Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months | 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. | baseline, post-intervention, 1 month, and 3 months |
| Fort Wayne |
| Indiana |
| 46805 |
| United States |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Marital Status | Number | participants |
|
| Education | Reported education | Number | participants |
|
| Household Income | Self-reported combined annual household income. | Number | participants |
|
| Self-Reported Health Rating | Number | participants |
|
| Living Arrangement | Self-reported current living arrangement. | Number | participants |
|
| REALM-R | REALM-R score. | Number | participants |
|
| OG001 | 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). |
|
|
|
| Secondary | Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months | 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. | Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score. | Posted | Mean | Standard Deviation | units on a scale | baseline, post-intervention, 1 month, and 3 months |
|
|
|
|
| Secondary | Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months | 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. | Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score. | Posted | Mean | Standard Deviation | units on a scale | baseline, post-intervention, 1 month, and 3 months |
|
|
|
|
| Secondary | Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months | 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. | Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score. | Posted | Mean | Standard Deviation | units on a scale | baseline, post-intervention, 1 month, and 3 months |
|
|
|
|
| Secondary | Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months | 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. | Due to errors in the data collection method, it is not possible to summarize the data for reporting. | Posted | baseline, post-intervention, 1 month, and 3 months |
|
|
| 0 |
| 194 |
| 0 |
| 194 |
| EG001 | 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). | 0 | 191 | 0 | 191 |
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| One-Month Planning Perception Score |
|
| Three-Month Planning Perception Score |
|
| Superiority or Other |
| One-Month CAHS Score |
|
| Three-Month CAHS Score |
|
| Superiority or Other |
| One-Month UHS Score |
|
| Three-Month UHS Score |
|
| Superiority or Other |