PlanYourLifespan.org for Cognitive Impairment

Overseen By Lee A Lindquist, MD, MBA, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Previous study participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

293 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to better understand how older adult aging-in-place/long term care decision making and implementation is impacted by age-related changes (e.g. cognition, health literacy, chronic conditions), social influences (e.g. caregivers/supporters), and environmental factors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PlanYourLifespan.org for Cognitive Impairment?

The Digital Memory Notebook intervention, which is similar to PlanYourLifespan.org, showed that participants with cognitive impairment experienced significant improvements in memory lapses, daily functioning, and quality of life. This suggests that digital interventions can be effective in supporting individuals with cognitive challenges. ^{1 2 3 4 5}

Is PlanYourLifespan.org safe for people with cognitive impairment?

The study on home-based virtual reality exercise for people with mild cognitive impairment found it to be safe, with no major adverse events reported. Participants enjoyed the program and reported physical benefits, indicating that such interventions are generally safe for this population. ^{6 7 8 9 10}

How does PlanYourLifespan.org for Cognitive Impairment differ from other treatments?

PlanYourLifespan.org is unique because it focuses on advance care planning (ACP) for individuals with cognitive impairment, helping them make important healthcare decisions before they lose the ability to do so. Unlike traditional treatments that may focus on medical or pharmaceutical interventions, this approach emphasizes planning and decision-making support, which is crucial for managing future healthcare needs. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for older adults who are part of the LitCog Trial, speak English, live in their own home, and use a computer or tablet with internet. It's not open to those who were in the Advanced Planning for Home Services study.

Inclusion Criteria

Currently use a computer or tablet with internet

You live in a community, not in a hospital or care facility.

English-speaking

Exclusion Criteria

Previous participation in the Advanced Planning for Home Services study [IH-12-11-4259]

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are given access to PlanYourLifespan.org, a web-based decision-making and planning tool

36 months

Online access with periodic assessments

Follow-up

Participants are monitored for decision-making changes and implementation of long-term care plans

6 months

Assessments every six months

Extended Follow-up

Continued monitoring of decision-making and plan implementation up to 42 months

6 months

Treatment Details

Interventions

• PlanYourLifespan.org

Trial Overview The study examines how an online tool called PlanYourLifespan.org affects decision-making regarding living arrangements and long-term care plans among seniors with cognitive challenges like Alzheimer's.

Participant Groups

Group I: Access to Web-Based Intervention Experimental Treatment 1 Intervention

All study participants will be given access to the web-based study intervention, PlanYourLifespan.org.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The Digital Memory Notebook (DMN) app was developed to assist older individuals with memory loss, and a manual-based intervention showed promising results in improving everyday memory and functioning among participants.

In a series of three case studies, two participants reported significant reductions in memory lapses and improved daily functioning, while all participants demonstrated enhanced coping skills and satisfaction with life after using the DMN app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a manual-based digital memory notebook intervention with case study illustrations. Chudoba, LA., Church, AS., Dahmen, JB., et al.[2023]

In a 12-week intervention trial involving 127 elderly patients with Mild Cognitive Impairment (MCI), 84% showed significant improvements in cognitive function after participating in a personalized Brain Fitness Program.

Among a subset of 17 patients who underwent MRI scans, 12 exhibited either no hippocampal atrophy or an increase in hippocampal volume, suggesting potential for reversing cognitive decline associated with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Personalized 12-week "Brain Fitness Program" for Improving Cognitive Function and Increasing the Volume of Hippocampus in Elderly with Mild Cognitive Impairment. Fotuhi, M., Lubinski, B., Trullinger, M., et al.[2022]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

In a 48-week trial followed by a 28-week extension study involving 821 patients with amnestic mild cognitive impairment (aMCI), donepezil (10 mg) was found to be generally safe and well-tolerated, with most adverse events being mild to moderate in severity.

The most common side effects included diarrhea, muscle spasms, insomnia, and nausea, with a higher discontinuation rate due to adverse events in the placebo group (22.1%) compared to the donepezil group (10.3%), indicating that donepezil is better tolerated than placebo in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study. Doody, RS., Ferris, S., Salloway, S., et al.[2018]

A study involving 16 participants aged 65 and older showed that older adults with mild cognitive impairment (MCI) found physical activity apps like Sworkit® and 7-Minute Workout® easy to use and enjoyable, with 100% of participants smiling while playing these games.

In contrast, cognitive training apps were less engaging, with only 35% of participants smiling, indicating that physical activity apps may be more appealing and effective for this population, highlighting the importance of user feedback in app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Usability of Physical Activity and Cognitive Training Applications in People With Mild Cognitive Impairment. Smith, L., Argentina, V.[2021]

The PREPAREforYourCare.org advance care planning program was found to be feasible and user-friendly for 20 older adults with mild-to-moderate cognitive impairment and their caregivers, with high satisfaction ratings (mean of 8.6 for patients and 9.4 for caregivers on a 10-point scale).

After using the program for one week, 80% of participants showed increased engagement in advance care planning, with caregivers reporting significant improvements in knowledge and self-efficacy, indicating the program's potential to enhance decision-making support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Diverse Older Adults With Cognitive Impairment and Caregivers in Advance Care Planning: A Pilot Study of the Interactive PREPARE Website. Kotwal, AA., Barnes, DE., Volow, AM., et al.[2023]

The development of the ACPVoice tool involved cognitive interviews with 20 participants, including individuals with mild cognitive impairment and their care partners, to ensure the tool was understandable and user-friendly for older adults with cognitive challenges.

Revisions to the wording and format of the tool significantly enhanced comprehension and response accuracy, suggesting that such tailored approaches can effectively engage community-dwelling individuals with cognitive impairment in advance care planning discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Advance Care Planning Portal-Based Tool for Community-Dwelling Persons Living With Cognitive Impairment: The ACPVoice Tool. Gabbard, J., Strahley, AE., Pajewski, NM., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The development of a manual-based digital memory notebook intervention with case study illustrations. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Hospital outcomes of older people with cognitive impairment: An integrative review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The impact of a cognitive impairment support program on patients in an acute care setting: a pre-test post-test intervention study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Screening for Cognitive Impairment in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Personalized 12-week "Brain Fitness Program" for Improving Cognitive Function and Increasing the Volume of Hippocampus in Elderly with Mild Cognitive Impairment. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Preventing disability in older adults with mild cognitive impairment: A Strategy Training intervention study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Trans-Theoretical Model-Based Health Education Program on the Management of Cognitive Dysfunction in Older Adults With Mild Cognitive Impairment: Study Rationale and Protocol Design for a Randomized Controlled Trial. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The Usability of Physical Activity and Cognitive Training Applications in People With Mild Cognitive Impairment. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Engaging Diverse Older Adults With Cognitive Impairment and Caregivers in Advance Care Planning: A Pilot Study of the Interactive PREPARE Website. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Information on advance care planning on websites of dementia associations in Europe: A content analysis. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Development of an Advance Care Planning Portal-Based Tool for Community-Dwelling Persons Living With Cognitive Impairment: The ACPVoice Tool. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Factors associated with initiation of advance care planning in dementia: a systematic review. [2018]

15. England pubmed.ncbi.nlm.nih.gov

Alleviation of carer strain during the use of the NeuroPage device by people with acquired brain injury. [2021]