NCT05462626

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

October 10, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

June 28, 2022

Last Update Submit

October 8, 2024

Conditions

Keywords

Occupational TherapyTelehealthCommunity Dwelling Older AdultsHealth LiteracySocial Determinants of HealthLifestyle Intervention

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

the Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program

EXPERIMENTAL

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).

Behavioral: Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program

Interventions

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.

the Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Related 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

    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.

    PMID: 20637084BACKGROUND
  • 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

    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

    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.

    PMID: 9343462BACKGROUND
  • 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.

    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.

    PMID: 21636614BACKGROUND
  • 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.

    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.

    PMID: 31319745BACKGROUND
  • 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.

    PMID: 20500222BACKGROUND
  • National Council on Aging. (2021). Get the facts on healthy aging. https://www.ncoa.org/article/get-the-facts-on-healthy-aging

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

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

    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

    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

    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.

    PMID: 34930542BACKGROUND
  • 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.

    PMID: 10848144BACKGROUND
  • 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.

    PMID: 32804713BACKGROUND
  • 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.

    PMID: 19179355BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 18, 2022

Study Start

July 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

October 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations