A Telehealth Lifestyle Intervention for Community-Dwelling Older Adults

NCT ID: NCT05462626

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate if an occupational therapy lifestyle program for community-dwelling older adults delivered individually through a telehealth platform can produce comparable outcomes in health-related qualify of life and occupational performance as found in studies that used a longer duration and group intervention.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Eighty percent of older adult Americans live with at least one chronic disease and 70% manage two or more. Chronic diseases pose significant health and economic costs to individual older adults, burden families due to increased care dependency, and cause substantial strain on the healthcare system. Older adults residing in rural and non-urban communities in particular face additional health disparities due to lack of access or fewer options for health care services and providers. As one solution, telehealth can increase ease and access to health care services, deliver quality outcomes and comparable levels of satisfaction, and reduce costs for both the patient and the health care system. This quantitative pilot study will use a quasi-experimental approach with a single-group, pretest-posttest design to evaluate the effects of the Holistic Occupational Performance Empowerment (HOPE) lifestyle program to promote health-related quality of life and occupational performance of community-dwelling older adults.

Investigators anticipate recruiting 12 to 15 English-speaking, independent community-dwelling adults 65 years or older living in non-urban communities within 40 miles of Great Falls, Montana or Oregon City, Oregon. The participants will receive 1 goal-setting session in-person, 6 training sessions via telehealth, and 1 post-intervention debriefing session in-person across 8 weeks; each session will be 45-60 minutes. Each week will comprise one or more lifestyle topics that are based on the twelve modules described in the Lifestyle Redesign®️ manual. The sessions involve an introduction to a lifestyle topic with the investigator providing verbal and visual education, collaborative discussion and reflection, review of a participant's self-identified goals, recommendations and homework, and scheduling of the session for the subsequent week. By addressing health disparities and expanding access, occupational therapists will be more intentional in their delivery of telehealth lifestyle interventions and contribute to chronic disease prevention and reduction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lifestyle, Healthy Quality of Life Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This quantitative pilot study will use a quasi-experimental approach with a single-group, pretest-posttest design to evaluate the effects of the Holistic Occupational Performance Empowerment (HOPE) lifestyle program on health-related quality of life and occupational performance of community-dwelling older adults.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program

The intervention will consist of six individualized sessions that will be conducted via a telehealth platform, each lasting about 45-60 minutes. Individual sessions allow for the participant's personal health factors to be discussed and reflected upon as the intervention is delivered weekly. Each week will comprise one or more lifestyle topics that are based on the twelve modules described in the Lifestyle Redesign® manual (Clark et al., 2015).

Group Type EXPERIMENTAL

Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program

Intervention Type BEHAVIORAL

The intervention is comprised of the following sessions and themes; Session 1: Informed Consent and Pre-Testing; Session 2: Occupation and Healthy Aging; Session 3: Longevity and Thriving; Session 4: Movement Matters; Session 5: Thoughtful Eating; Session 6: Stress and Sleep; Session 7: Navigating Health Care; Session 8: Post-Testing and Discharge.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program

The intervention is comprised of the following sessions and themes; Session 1: Informed Consent and Pre-Testing; Session 2: Occupation and Healthy Aging; Session 3: Longevity and Thriving; Session 4: Movement Matters; Session 5: Thoughtful Eating; Session 6: Stress and Sleep; Session 7: Navigating Health Care; Session 8: Post-Testing and Discharge.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults 65 years or older
* English-speaking
* Independent community-dwellers
* Living in non-urban communities within 40 miles of Great Falls, Montana or Oregon City, Oregon
* Self-reported adequate vision, with or without corrective lenses, to view and read paper-based and electronic materials with a minimum 12-point font size
* Demonstrate reasonable technology skills (e.g., access email and telehealth platform) with or without the help of a family member or caregiver
* Have consistent access to an electronic device that has Wi-Fi connection

Exclusion Criteria

* Require any human assistance with activities of daily living
* Score of less than 12 out of 15 on 5-minute telephone version of the Montreal Cognitive Assessment
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Creighton University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Creighton University

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Amdie, F. Z., & Woo, K. (2020). The use of mHealth technology for chronic disease management: The challenges and opportunities for practical application. Wounds International, 11(2), 32-38. https://www.woundsinternational.com/resources/details/the-use-of-mhealth-technology-for-chronic-disease-management-the-challenges-and-opportunities-for-practical-application

Reference Type BACKGROUND

Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.

Reference Type BACKGROUND
PMID: 20637084 (View on PubMed)

Cahill, S. (2021). Research update on telehealth: Client outcomes and satisfaction, occupation-based coaching, and stroke rehabilitation. American Occupational Therapy Association. https://www.aota.org/publications/ot-practice/ot-practice- issues/2021/research-update-telehealth

Reference Type BACKGROUND

Centers for Disease Control and Prevention. (2009). The power of prevention: Chronic disease...the public health challenge of the 21st century. National Center for Chronic Disease Prevention and Health Promotion. https://www.cdc.gov/chronicdisease/pdf/2009-power-of-prevention.pdf

Reference Type BACKGROUND

Clark F, Azen SP, Zemke R, Jackson J, Carlson M, Mandel D, Hay J, Josephson K, Cherry B, Hessel C, Palmer J, Lipson L. Occupational therapy for independent-living older adults. A randomized controlled trial. JAMA. 1997 Oct 22-29;278(16):1321-6.

Reference Type BACKGROUND
PMID: 9343462 (View on PubMed)

Clark, F. A., Blanchard, J., Sleight, A., Cogan, A., Florindez, L., Gleason, S., Heymann, R., Hill, V., Holden, A., Murphy, M. Proffitt, R., Schepens Niemiec, S., & Vigen, C. (2015). Lifestyle Redesign: The intervention tested in the USC Well Elderly Studies (2nd ed.) Bethesda, MD: AOTA Press.

Reference Type BACKGROUND

Clark F, Jackson J, Carlson M, Chou CP, Cherry BJ, Jordan-Marsh M, Knight BG, Mandel D, Blanchard J, Granger DA, Wilcox RR, Lai MY, White B, Hay J, Lam C, Marterella A, Azen SP. Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial. J Epidemiol Community Health. 2012 Sep;66(9):782-90. doi: 10.1136/jech.2009.099754. Epub 2011 Jun 2.

Reference Type BACKGROUND
PMID: 21636614 (View on PubMed)

Edmonds, W. A., & Kennedy, T. D. (2010). A reference guide to basic research design: A visual system for research design in education and the social and behavioral sciences. Pearson Learning Solutions.

Reference Type BACKGROUND

Gately ME, Trudeau SA, Moo LR. Feasibility of Telehealth-Delivered Home Safety Evaluations for Caregivers of Clients With Dementia. OTJR (Thorofare N J). 2020 Jan;40(1):42-49. doi: 10.1177/1539449219859935. Epub 2019 Jul 18.

Reference Type BACKGROUND
PMID: 31319745 (View on PubMed)

Lee SY, Stucky BD, Lee JY, Rozier RG, Bender DE. Short Assessment of Health Literacy-Spanish and English: a comparable test of health literacy for Spanish and English speakers. Health Serv Res. 2010 Aug;45(4):1105-20. doi: 10.1111/j.1475-6773.2010.01119.x. Epub 2010 May 24.

Reference Type BACKGROUND
PMID: 20500222 (View on PubMed)

National Council on Aging. (2021). Get the facts on healthy aging. https://www.ncoa.org/article/get-the-facts-on-healthy-aging

Reference Type BACKGROUND

Nesreddine, Z. (2021). Mini Montreal Cognitive Assessment (Mini MoCA) version 2.1: Administration and scoring instructions. www.mocatest.org

Reference Type BACKGROUND

Portney, L. G. (2020). Foundations of clinical research (4th ed.). FA Davis.

Reference Type BACKGROUND

RAND Corporation. (n.d.). More about the 20-item short form survey (SF-20). https://www.rand.org/health-care/surveys_tools/mos/20-item-short-form/more.html

Reference Type BACKGROUND

Rural Health Information Hub. (2019). Rural health disparities. Health Resources and Services Administration, United States Department of Health and Human Services https://www.ruralhealthinfo.org/topics/rural-health-disparities#causes

Reference Type BACKGROUND

Solomon GM, Bailey J, Lawlor J, Scalia P, Sawicki GS, Dowd C, Sabadosa KA, Van Citters A. Patient and family experience of telehealth care delivery as part of the CF chronic care model early in the COVID-19 pandemic. J Cyst Fibros. 2021 Dec;20 Suppl 3:41-46. doi: 10.1016/j.jcf.2021.09.005.

Reference Type BACKGROUND
PMID: 34930542 (View on PubMed)

Stolee P, Zaza C, Pedlar A, Myers AM. Clinical experience with Goal Attainment Scaling in geriatric care. J Aging Health. 1999 Feb;11(1):96-124. doi: 10.1177/089826439901100106.

Reference Type BACKGROUND
PMID: 10848144 (View on PubMed)

Tenforde AS, Borgstrom H, Polich G, Steere H, Davis IS, Cotton K, O'Donnell M, Silver JK. Outpatient Physical, Occupational, and Speech Therapy Synchronous Telemedicine: A Survey Study of Patient Satisfaction with Virtual Visits During the COVID-19 Pandemic. Am J Phys Med Rehabil. 2020 Nov;99(11):977-981. doi: 10.1097/PHM.0000000000001571.

Reference Type BACKGROUND
PMID: 32804713 (View on PubMed)

Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clin Rehabil. 2009 Apr;23(4):362-70. doi: 10.1177/0269215508101742. Epub 2009 Jan 29.

Reference Type BACKGROUND
PMID: 19179355 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2002841

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

In-home Yoga for Seniors
NCT05287529 COMPLETED NA
Promoting Aging in Place Through A Wellness Program
NCT06569576 ACTIVE_NOT_RECRUITING NA
Sit Less for Successful Aging
NCT03537677 COMPLETED NA
Tele-Yoga Therapy for Chronic Pain
NCT04457388 COMPLETED NA