Alzheimers, Falls, Aging in Place
Conditions
Keywords
aging, geriatrics, aging in place, home services
Brief summary
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.
Detailed description
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.
Interventions
OTHERPlan 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 interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
OTHERGo4Life 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).
Sponsors
Patient-Centered Outcomes Research Institute
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 65 and older * English speaking * Score ≥ 4 questions correctly on the Brief Cognitive screener * Self-identified comfort using a computer * Self-identified comfort using the Internet to navigate a Website * Have not previously participated in study's focus groups or pilot study
Exclusion criteria
* Less than age 65 * Non-English speaking * Score \< 4 questions correctly on the Brief Cognitive screener * Not comfortable using a computer * Not comfortable using the Internet to navigate a Website * Previous participation in this study's focus groups or pilot study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Planning Behavior Score at 1-month | baseline and 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months | baseline, post-intervention, 1 month, 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. |
| Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months | baseline, post-intervention, 1 month, 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. |
| Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months | baseline, post-intervention, 1 month, 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. |
| Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months | baseline, post-intervention, 1 month, 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment for this study took place between October 1, 2014 and September 30, 2015.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 194 |
| 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). | 191 |
| Total | 385 |
Baseline characteristics
| Characteristic | Plan Your Lifespan Website | Total | Go4Life Website |
|---|---|---|---|
| Age, Continuous | 71.67 years STANDARD_DEVIATION 5.56 | 71.86 years STANDARD_DEVIATION 5.56 | 72.05 years STANDARD_DEVIATION 5.57 |
| Education College graduate | 95 participants | 198 participants | 103 participants |
| Education High school or less | 40 participants | 73 participants | 33 participants |
| Education Some college | 59 participants | 114 participants | 55 participants |
| Household Income $20,000-$40,000 | 54 participants | 104 participants | 50 participants |
| Household Income $40,001-$60,000 | 27 participants | 58 participants | 31 participants |
| Household Income $60,001-$80,000 | 26 participants | 51 participants | 25 participants |
| Household Income $80,001-$100,000 | 17 participants | 36 participants | 19 participants |
| Household Income less than $20,000 | 43 participants | 88 participants | 45 participants |
| Household Income More than $100,000 | 18 participants | 31 participants | 13 participants |
| Household Income Not Sure/Don't Know | 2 participants | 6 participants | 4 participants |
| Household Income Prefer not to say | 7 participants | 11 participants | 4 participants |
| Living Arrangement Live alone | 94 participants | 198 participants | 104 participants |
| Living Arrangement Live with multiple people (more than one) | 10 participants | 22 participants | 12 participants |
| Living Arrangement Live with one other person | 90 participants | 165 participants | 75 participants |
| Marital Status Divorced/Separated | 50 participants | 95 participants | 45 participants |
| Marital Status Married | 85 participants | 160 participants | 75 participants |
| Marital Status Single, never married | 23 participants | 50 participants | 27 participants |
| Marital Status Widowed | 36 participants | 80 participants | 44 participants |
| Race/Ethnicity, Customized Black or African American | 55 participants | 93 participants | 38 participants |
| Race/Ethnicity, Customized Hispanic | 8 participants | 17 participants | 9 participants |
| Race/Ethnicity, Customized More than one race | 9 participants | 23 participants | 14 participants |
| Race/Ethnicity, Customized Other | 5 participants | 10 participants | 5 participants |
| Race/Ethnicity, Customized White or Caucasian | 117 participants | 242 participants | 125 participants |
| REALM-R Adequate Literacy | 165 participants | 324 participants | 159 participants |
| REALM-R Low Literacy | 1 participants | 4 participants | 3 participants |
| REALM-R Marginal Literacy | 28 participants | 57 participants | 29 participants |
| Self-Reported Health Rating Excellent | 21 participants | 48 participants | 27 participants |
| Self-Reported Health Rating Fair | 18 participants | 40 participants | 22 participants |
| Self-Reported Health Rating Good | 81 participants | 157 participants | 76 participants |
| Self-Reported Health Rating Poor | 4 participants | 8 participants | 4 participants |
| Self-Reported Health Rating Very Good | 70 participants | 132 participants | 62 participants |
| Sex: Female, Male Female | 149 Participants | 306 Participants | 157 Participants |
| Sex: Female, Male Male | 45 Participants | 79 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 194 | 0 / 191 |
| serious Total, serious adverse events | 0 / 194 | 0 / 191 |
Outcome results
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%.
Time frame: baseline and 1 month
Population: All randomized participants with a complete planning behavior score at baseline and one-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plan Your Lifespan Website | Planning Behavior Score at 1-month | Baseline Planning Behavior Score | 16.97 units on a scale | Standard Deviation 4.38 |
| Plan Your Lifespan Website | Planning Behavior Score at 1-month | One Month Planning Behavior Score | 17.19 units on a scale | Standard Deviation 4.48 |
| Go4Life Website | Planning Behavior Score at 1-month | Baseline Planning Behavior Score | 16.80 units on a scale | Standard Deviation 4.58 |
| Go4Life Website | Planning Behavior Score at 1-month | One Month Planning Behavior Score | 15.88 units on a scale | Standard Deviation 4.56 |
Comparison: H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.p-value: 0.005495% CI: [0.37, 2.12]ANCOVA
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.
Time frame: baseline, post-intervention, 1 month, and 3 months
Population: Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Go4Life Website | Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months | Three-Month CAHS Score | 21.70 units on a scale | Standard Deviation 2.71 |
| Go4Life Website | Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months | Baseline CAHS Score | 20.70 units on a scale | Standard Deviation 3.45 |
| Go4Life Website | Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months | One-Month CAHS Score | 21.19 units on a scale | Standard Deviation 2.93 |
| Go4Life Website | Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months | Post-Tool CAHS Score | 20.67 units on a scale | Standard Deviation 3.37 |
Comparison: H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.p-value: 0.423Mixed Models Analysis
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.
Time frame: baseline, post-intervention, 1 month, and 3 months
Population: Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Go4Life Website | Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months | Three-Month UHS Score | 3.73 units on a scale | Standard Deviation 1.37 |
| Go4Life Website | Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months | Baseline UHS Score | 3.79 units on a scale | Standard Deviation 1.27 |
| Go4Life Website | Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months | One-Month UHS Score | 3.72 units on a scale | Standard Deviation 1.39 |
| Go4Life Website | Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months | Post-Tool UHS Score | 3.93 units on a scale | Standard Deviation 1.21 |
Comparison: Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.p-value: <0.0001Mixed Models Analysis
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.
Time frame: baseline, post-intervention, 1 month, and 3 months
Population: Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Plan Your Lifespan Website | 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 |
| Go4Life Website | Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months | Three-Month Planning Perception Score | 20.81 units on a scale | Standard Deviation 3.56 |
| Go4Life Website | Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months | Baseline Planning Perception Score | 20.11 units on a scale | Standard Deviation 3.64 |
| Go4Life Website | Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months | One-Month Planning Perception Score | 20.29 units on a scale | Standard Deviation 3.61 |
| Go4Life Website | Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months | Post-Tool Planning Perception Score | 20.01 units on a scale | Standard Deviation 3.74 |
Comparison: Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.p-value: 0.0471Mixed Models Analysis
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.
Time frame: baseline, post-intervention, 1 month, and 3 months
Population: Due to errors in the data collection method, it is not possible to summarize the data for reporting.