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Lifestyle, HealthyNCT05462626

A Telehealth Lifestyle Intervention for Community-Dwelling Older Adults

A study testing Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program in people with Lifestyle, Healthy and Quality of Life, run by Creighton University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Lifestyle, Healthy, Quality of Life, Aging
What is being tested?
Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Jul 2022to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Creighton University

    Omaha, Nebraska, 68131

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program
Keywords
Occupational Therapy, Telehealth, Community Dwelling Older Adults, Health Literacy, Social Determinants of Health, Lifestyle Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Holistic Occupational Performance Empowerment (HOPE) Lifestyle ProgramBehavioural

    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.

Study groups in NCT05462626
Study groupRoleWhat they receive
the Holistic Occupational Performance Empowerment (HOPE) Lifestyle ProgramExperimentalThe 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).
Receives: Behavioral: Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention

  2. 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.

    Measured: 2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention

  3. 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.

    Measured: 1 Week Pre-Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start1 Jul 2022
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05462626
Sponsor's protocol ID
2002841
Status last verified
Jul 2024
First submitted
28 Jun 2022
Last updated
10 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20637084

  • 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.

    PubMed 9343462

  • 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.

  • 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.

    PubMed 21636614

  • 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.

    PubMed 31319745

  • 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.

    PubMed 20500222

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program in people with Lifestyle, Healthy and Quality of Life, run by Creighton University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Scores of 20-Item Short Form Survey (time frame: 2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05462626, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.

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