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Advance Planning for Home Services for Seniors (APHS)

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ClinicalTrials.gov Identifier: NCT02256072
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : February 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Lee Lindquist, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Alzheimers, Falls, Aging in Place Other: Plan Your Lifespan Website Other: Go4Life Website Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Advance Planning for Home Services for Seniors
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Plan Your Lifespan Website
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.
Other: 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.

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.
Other: 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).
Other Name: National Institute on Aging at NIH Website




Primary Outcome Measures :
  1. Planning Behavior Score at 1-month [ Time Frame: 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 Outcome Measures :
  1. Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months [ Time Frame: 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.

  2. Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months [ Time Frame: 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.

  3. Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months [ Time Frame: 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.

  4. Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256072


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Aging & In-Home Services of Northeast Indiana
Fort Wayne, Indiana, United States, 46805
Sponsors and Collaborators
Northwestern University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Lee A Lindquist, MD, MPH, MBA Northwestern University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lee Lindquist, Associate Professor of Medicine, Associate Division Chief of Geriatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT02256072     History of Changes
Other Study ID Numbers: IH-12-11-4259
First Posted: October 3, 2014    Key Record Dates
Results First Posted: February 14, 2017
Last Update Posted: April 14, 2017
Last Verified: March 2017

Keywords provided by Lee Lindquist, Northwestern University:
aging, geriatrics, aging in place, home services