Overview

This trial is active, not recruiting.

Condition alzheimers, falls, aging in place
Treatments plan your lifespan website, go4life website
Sponsor Northwestern University
Collaborator Patient Centered Outcome Research Institute
Start date September 2014
End date December 2015
Trial size 600 participants
Trial identifier NCT02256072, IH-12-11-4259

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(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.
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 interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
(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.
go4life website National Institute on Aging at NIH 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).

Primary Outcomes

Measure
Change in Planning Behavior Score at 3-months
time frame: baseline and 3 months

Secondary Outcomes

Measure
Change in Planning Perception Score at immediate post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months
Change in Confidence in Accessing Home Services Score at immediate post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months
Change in Knowledge of Home Services Score at immediate post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months
Change in Satisfaction with Intervention Tool Score at immediate post-test, 1 and 3-months
time frame: baseline, post-intervention, 1 month, and 3 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Advance Planning for Home Services for Seniors
Principal investigator Lee A Lindquist, MD, MPH, MBA
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) three months 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) three months 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) three months 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Northwestern University.