Life Story Questionnaire and Physical Therapy Participation

May 26, 2023 updated by: Jean Michel Brismee, Texas Tech University Health Sciences Center

Effects of the Life Story Questionnaire on Physical Therapy Participation in Patients With Dementia: A Randomized Control Trial

The goal of this clinical trial is to see the effect of life story questionnaire (LSQ) on physical therapy participation in patients with dementia. The main question[s] it aims to answer are:

  1. What is the effect of LSQ usage on physical therapy participation in people with dementia?
  2. What is the effect of LSQ usage on depression in people with dementia?
  3. What is the effect of LSQ usage on the quality of life in people with dementia? The researcher will compare these effects between the intervention group (usage of the Life Story Questionnaire) and the control group (no usage of the Life story questionnaire).

All Participants will receive Physical therapy treatment as usual. The life Story Questionnaire will be used in the intervention group during physical therapy treatment.

Life Story Questionnaire: It is developed by the Crisis Prevention Institute, which is a type of life story book for people with dementia. The LSQ allows caregivers to start conversations about topics that are important to each patient, can help establish rapport between the caregiver and patient.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Dementia is characterized by a progressive decline in cognitive function. Dementia disease prevalence is substantially increased among people aged 65 years or older, with a progressive decline in memory, thinking, language and learning capacity. Although physical exercise benefits dementia patients, participation in activities is exceedingly difficult due to communication and cognitive impairments. Several studies demonstrated that life story books usage improved quality of life, depression symptoms, moods and participation in activity in people with dementia. However, these studies did not evaluate the effect of Life Story Questionnaire (LSQ) - a type of life story book - on physical therapy participation, depression symptoms, quality of life.

Objectives: To evaluate the impact of LSQ on (1) participation in physical therapy using Pittsburgh Rehabilitation Participation Scale; (2) quality of life using Quality of Life - Alzheimer's Disease Scale (participant's version); and (3) depression symptoms using Cornell Scale for Depression in Dementia (CSDD).

Methods: A consecutive sample of convenience of up to 60 patients with mild to moderate cognitive impairment with 44 (22 per group) completing the study will be recruited from a nursing home facility. Patients will be randomly allocated in two groups: (1) Control group, which will receive standard physical therapy care without LSQ use; and (2) Experimental group, where physical therapists will use the LSQ. Each patient's family member will receive a LSQ to complete prior to the start of the intervention. Patients' participation, quality of life and depression symptoms will be measured on day 1 and again after 3 weeks (mid-term), and 6 weeks of intervention. Quality of life and depression symptoms will also be measured 6 weeks following intervention. A licensed occupational therapist blinded to the participants' group allocation will measure all three dependent variables

Statistical Analysis: Descriptive statistics including means, standard deviations, frequency counts, median, mode, variance and frequency counts will be used to assess sample demographics. The Rank Sum test will be used to assess differences in Pittsburgh Rehabilitation Participation Scale between the intervention and control group. Spearman Rank correlations will be used to determine the strength of the correlation between Mini-Mental state examination, Pittsburgh Rehabilitation Participation Scale and Quality of Life Alzheimer Disease.

Study Type

Interventional

Enrollment (Estimated)

60

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

Study Locations

  • United States
    • Texas
      • Weatherford, Texas, United States, 76086
        • Recruiting
        • Peachtree Place (Dementia care facility)
        • Contact:
        • Contact:
          • Lisa Brite, OT, BS
          • Phone Number: 817-599-4181

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients residing at dementia facility in Texas;
  2. Age 60-89 years;
  3. Diagnosis of dementia disease, in mild to the moderate stage using the Mini-Mental State Examination (score between 10 -24) and
  4. Attendance to physical therapy for 6 weeks.

Exclusion Criteria:

  1. Unable to speak English;
  2. Blindness;
  3. Deafness;
  4. Mini-Mental State Examination score >24 and
  5. history of major psychiatric disorders such as schizophrenia and bipolar disorder requiring hospital admission within the last year.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usage of Life Story Questionnaire
This group will receive 6 weeks of physical therapy treatment as usual with the usage of the Life story questionnaire.
Other: Life story questionnaire
Participant will receive physical therapy treatment as usual using information from Life Story Questionnaire.
No Intervention: No usage of Life Story Questionnaire
This group will receive 6 weeks of physical therapy treatment as usual with no usage of the Life Story Questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Rehabilitation Participation Scale
Time Frame: 1st week of physical therapy
To measure participation in physical therapy. Participation is graded as none (1), Poor (2), Fair (3), Good (4), Very good (5), and Excellent (6). Higher score indicates greater participation in physical therapy sessions.
1st week of physical therapy
Pittsburgh Rehabilitation Participation Scale
Time Frame: 3rd week of Physical Therapy
To measure participation in physical therapy. Participation is graded as none (1), Poor (2), Fair (3), Good (4), Very good (5), and Excellent (6). Higher score indicates greater participation in physical therapy sessions.
3rd week of Physical Therapy
Pittsburgh Rehabilitation Participation Scale
Time Frame: 6th week of Physical Therapy
To measure participation in physical therapy. Participation is graded as none (1), Poor (2), Fair (3), Good (4), Very good (5), and Excellent (6). Higher score indicates greater participation in physical therapy sessions.
6th week of Physical Therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in Alzheimer's disease scale- participant's version
Time Frame: 1st week of Physical Therapy
The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.
1st week of Physical Therapy
Quality of life in Alzheimer's disease scale- participant's version
Time Frame: 3rd week of Physical Therapy
The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.
3rd week of Physical Therapy
Quality of life in Alzheimer's disease scale- participant's version
Time Frame: 6th week of Physical Therapy
The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.
6th week of Physical Therapy
Quality of life - Alzheimer's disease - participant's version
Time Frame: 6 weeks following intervention of Physical Therapy
The quality of life in Alzheimer's disease scale rates 13 types of life domains and uses a scale of poor (1), fair (2), good (3), and excellent (4). Minimum score is 13 and maximum score is 52. Higher scores indicate better quality of life.
6 weeks following intervention of Physical Therapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cornell scale for depression in dementia
Time Frame: 1st week of Physical Therapy
It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression.
1st week of Physical Therapy
Cornell scale for depression in dementia
Time Frame: 3rd week of Physical Therapy
It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression.
3rd week of Physical Therapy
Cornell scale for depression in dementia
Time Frame: 6th week of Physical Therapy
It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression.
6th week of Physical Therapy
Cornell scale for depression in dementia
Time Frame: 6 weeks following intervention of Physical Therapy
It is a a screening tool and assesses depression symptoms in dementia participants. Score ranges from a - unable to evaluate, 0- absent, 1- mild, 2- severe. Minimum score is 0 and maximum score is 38. Higher scores indicate greater depression.
6 weeks following intervention of Physical Therapy

Collaborators and Investigators

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

Sponsor

Texas Tech University Health Sciences Center

Collaborators

Texas Tech University

Investigators

  • Principal Investigator: Jean-Michel Brismee, ScD, Texas Tech University Health Sciences Center
  • Principal Investigator: Jonathan Singer, PhD, Texas Tech 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

Helpful Links

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 (Actual)

April 26, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2023-103

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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