A Telehealth Lifestyle Intervention for Community-Dwelling Older Adults

July 15, 2022 updated by: Creighton University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Scores of 20-Item Short Form Survey
Time Frame: 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 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention
Change Scores of Goal Attainment Scaling
Time Frame: 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.
2 Times; 1 Week Pre-Intervention; 1 Week Post-Intervention
The Short Assessment of Health Literacy-English (SAHL-E)
Time Frame: 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.
1 Week Pre-Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 15, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2002841

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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