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Life Story Questionnaire and Physical Therapy Participation

Sponsor
Texas Tech University Health Sciences Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05827276
Collaborator
Texas Tech University (Other)
60
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Life story questionnaire
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective Randomized Control Trial. 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.Prospective Randomized Control Trial. 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.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The outcome assessor will be blind to the usage of the life story questionnaire for study participants. Additionally, the participants will not be told the group they were allocated to.
Primary Purpose:
Treatment
Official Title:
Effects of the Life Story Questionnaire on Physical Therapy Participation in Patients With Dementia: A Randomized Control Trial
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Rehabilitation Participation Scale [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.

  2. Pittsburgh Rehabilitation Participation Scale [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.

  3. Pittsburgh Rehabilitation Participation Scale [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.

Secondary Outcome Measures

  1. Quality of life in Alzheimer's disease scale- participant's version [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.

  2. Quality of life in Alzheimer's disease scale- participant's version [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.

  3. Quality of life in Alzheimer's disease scale- participant's version [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.

  4. Quality of life - Alzheimer's disease - participant's version [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.

Other Outcome Measures

  1. Cornell scale for depression in dementia [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.

  2. Cornell scale for depression in dementia [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.

  3. Cornell scale for depression in dementia [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.

  4. Cornell scale for depression in dementia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Texas Tech University Health Sciences Center
  • Texas Tech University

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Jean Michel Brismee, Principal co-investigator, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT05827276
Other Study ID Numbers:
  • IRB2023-103
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
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 Jean Michel Brismee, Principal co-investigator, Texas Tech University Health Sciences Center
Dementia
Life story questionnaire
Physical therapy
Physiotherapy
Participation
Exercise
Additional relevant MeSH terms:
Dementia
Alzheimer Disease

Study Results

No Results Posted as of Apr 26, 2023