A Telehealth Lifestyle Intervention for Community-Dwelling Older Adults

Sponsor
Creighton University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05462626
Collaborator
(none)
12
1
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Holistic Occupational Performance Empowerment (HOPE) Lifestyle Program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Quality of Life and Occupational Performance in Community-Dwelling Older Adults: A Telehealth Lifestyle Pilot
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

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.

Outcome Measures

Primary Outcome Measures

  1. Change Scores of 20-Item Short Form Survey [2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention]

    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. Change Scores of Goal Attainment Scaling [2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention]

    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.

  3. The Short Assessment of Health Literacy-English (SAHL-E) [1 Week Pre-Intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Creighton University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Creighton University
ClinicalTrials.gov Identifier:
NCT05462626
Other Study ID Numbers:
  • 2002841
First Posted:
Jul 18, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Creighton University

Study Results

No Results Posted as of Jul 18, 2022