A Telehealth Lifestyle Intervention for Community-Dwelling Older Adults

Quality of Life Clinical Trial

Official title:

Quality of Life and Occupational Performance in Community-Dwelling Older Adults: A Telehealth Lifestyle Pilot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05462626
• Other study ID #: 2002841
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: May 2023

Study information

• Verified date: July 2022
• Source: Creighton University
• Contact: Julia Shin, EdD, OTR/L
• Phone: (402) 280 - 4327
• Email: JuliaShin[@]creighton.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Lifestyle, Healthy
• Quality of Life

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

References & Publications (19)

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

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. Review. — View Citation

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

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

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. — View Citation

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. Erratum in: J Epidemiol Community Health. 2012 Nov;66(11):1082. — View Citation

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.

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.

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. — View Citation

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. — View Citation

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

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

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

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Clin Rehabil. 2010 Feb;24(2):191. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Scores of 20-Item Short Form Survey	The 20-Item Short Form Survey (SF-20) is a shortened form of the original 36-item questionnaire created for the Medical Outcomes Study. The SF-20 utilizes close-ended, Likert-type questions to address self-reported health-related quality of life within six domains: physical functioning, role functioning, social functioning, mental health, current health perceptions, and pain. Raw scores from the 20 items are transformed linearly into 0-100 scales for each of the six domains. Higher scores indicate better physical, role, and social functioning, better mental health and health perceptions, and more pain.	2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention
Primary	Change Scores of Goal Attainment Scaling	Goal attainment scaling (GAS) is a method of scoring the extent to which a participant's individualized goals are achieved over the course of an intervention. The participants will be asked to identify three occupation-based, lifestyle-focused SMART (specific, measurable, attainable, realistic, and timely) goals. Goals are weighted based on the participant's rating of importance and level of difficulty on a scale of 0 to 3 where higher scores indicate greater importance and greater difficulty, respectively. Each goal is also rated on a 5-point scale capturing a degree of attainment, the expected outcome at pre-intervention, and the achieved outcome at post-intervention. Scores can range from -2 to +2 where a median score of 0 indicates goals were achieved as expected, negative scores indicate goals with worse than expected outcomes, and positive scores indicate goals with better than expected outcomes.	2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention
Primary	The Short Assessment of Health Literacy-English (SAHL-E)	The Short Assessment of Health Literacy-English (SAHL-E) is an 18-item test designed to help health professionals assess the ability of English-speaking adults to read and understand common medical terms. Participants score between 0 and 18 points with higher scores indicating better health literacy. Scores of 14 or below indicate low health literacy.	1 Week Pre-Intervention