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Occupational Therapy and Cognitive Challenges After Brain Injury

Primary Purpose

Brain Injuries, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The Perceive, Recall, Plan and Perform System of Intervention
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Task Performance, Occupational Therapy, Community Health Services, Elderly, The Perceive, Recall, Plan and Perform System, Rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admission to the health centres in the two municipalities
  • Acquired brain injury
  • Mastery under 85% of PRPP Assessment stage 1

Exclusion Criteria:

  • An already diagnosed dementia or progressive brain disorder
  • Congenital brain injury or neurological developmental disorder
  • Not able to understand or hear instructions, due to foreign language, severe hearing loss or severe arousal problems
  • Physical disabilities that hinder performance of most daily activities.
  • If a participant show mastery above 85% of PRPP Assessment stage 1, the participant either need to be assessed in more taxonomic difficult activities or will be excluded with 'no cognitive challenges in occupational performance'.

Sites / Locations

  • Østre Toten Municipality, Department of Physio- and Occupational TherapyRecruiting
  • Skien Municipality, Department of Rehabilitation and Palliative CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRPP Intervention

Arm Description

This baseline phase will be 3, 5 or 7 days, and intervention phase starts immediately after baseline with 45-60 minutes PRPP Intervention 3 times a week for 3 weeks.

Outcomes

Primary Outcome Measures

Change in task performance
Five everyday tasks will be target behavior, and each will be divided into a series of significant steps and measured in percentage mastery of the steps according to "The Perceive, Recall, Plan and Perform Assessment stage 1" as a functional measure. The highest score is 100% mastery of the steps, and the lowest is 0%, where none of the steps have appropriate mastery. With a score above 85% the participant is considered as independent, but with minor errors in performance.

Secondary Outcome Measures

Change in cognitive strategy application
"The Perceive, Recall, Plan and Perform Assessment stage 2" (PRPP) is used to measure the effectiveness of 34 observable cognitive strategy application behaviours in the everyday task performance.The PRPP Assessment stage 2 is criterion-referenced and evaluated in a three-point scale: (3) effective task performance, (2) questionable or (1) not effective. An effective performance in all the observable strategies will give a score of 102 points and with the lowest outcome of 34 points if all the cognitive strategy applications are not effective. For the therapist it will be even more valuable to notice which of the cognitive strategies that are not effective, as a foundation for the intervention.

Full Information

First Posted
October 29, 2021
Last Updated
August 14, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
Østre Toten Municipality, Skien Municipality
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1. Study Identification

Unique Protocol Identification Number
NCT05148247
Brief Title
Occupational Therapy and Cognitive Challenges After Brain Injury
Official Title
Evaluation of The Perceive, Recall, Plan and Perform Intervention for Persons With Cognitive Impairments After Brain Injuries in Community Rehabilitation: Single Case Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Østre Toten Municipality, Skien Municipality

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: There is a need for standardized interventions in community rehabilitation that can improve everyday task performance for older adults with cognitive challenges after acquired brain injury. Older adults are often excluded from research due to strict inclusion criteria. It is critical for a sustainable health service system that these patients are empowered and reach their maximum level of independence. The Perceive, Recall, Plan and Perform System (PRPP) of Intervention can be applied by Occupational Therapists (OT) for clients with cognitive challenges to enhance mastery of needed or desired everyday tasks. There is no current evidence for the effectiveness of this intervention for this population. Purpose: A clinical trial to investigate the effectiveness of the PRPP intervention for older persons with cognitive impairments after brain injury in the context of community-based rehabilitation. Method: In PRPP intervention the OT uses systematically instructions in task training to support a client to use cognitive strategies efficiently. The everyday tasks used for training should be valued by the participant and useful in their rehabilitation. The tasks could include different parts of morning routines, simple or complex meal planning or preparation, use of cell phone, leisure activities, or other household and community activities. At best the skills are generalized throughout all everyday activities, and the OTs' role as a cognitive mediator fades as participants internalize the strategies. The participants receive PRPP intervention 3 times a week for 3 weeks, every session last for 45-60 minutes. The participants' task mastery and cognitive strategy use will be measured at least 5 times in each phase: baseline, intervention, after the intervention, and 4 weeks after the discharge from rehabilitation. The measurement scores at baseline act controls and are therefore compared with the other phases for the same participant. The same procedure will be repeated for the other participants, but then with a staggered intervention phase. A staggered intervention phase acts as a control between participants and allows to see if changes occur only when the intervention is introduced. Implications for practice: The investigators assume that this systematic intervention will improve everyday task performance, and will in turn contribute to empowerment and independence of older adults with cognitive challenges after brain injuries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Cognitive Impairment
Keywords
Task Performance, Occupational Therapy, Community Health Services, Elderly, The Perceive, Recall, Plan and Perform System, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-Case Experimental Designs with Multiple baselines across participants. At least five data collection points within 4 phases (= at least 20 data points) for each participant (= one tier), and a minimum of three participants (= one sample), is recommended to meet design quality standards. The 'Number of Arms' will in this tradition mean one tier. Data for at least 2 samples will be collected, each of 3 tiers.
Masking
None (Open Label)
Masking Description
Participants are randomized to three different baseline-lengths in each tier, that serve as control data in this design. Blinding is not possible for the conducting OT, but an independent PRPP-trained OT assesses 20 % of the PRPP stage 1 and 2 measurements from each phase by videotaping the assessment situations. The tapes will be presented blinded and randomly for this second and blinded assessor.
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRPP Intervention
Arm Type
Experimental
Arm Description
This baseline phase will be 3, 5 or 7 days, and intervention phase starts immediately after baseline with 45-60 minutes PRPP Intervention 3 times a week for 3 weeks.
Intervention Type
Behavioral
Intervention Name(s)
The Perceive, Recall, Plan and Perform System of Intervention
Other Intervention Name(s)
PRPP
Intervention Description
The aim of the PRPP intervention is to enhance mastery in performance of needed or desired occupations, and extend traditional task training. Systematic instructions to support the clients' cognitive capacity to think about doing in different tasks and contexts are given by the OT, based on the results of PRPP Assessment stage 2. Further, the OT uses graded verbal, visual or physical prompts and cues directly during the participants task performance, progressing from content-free meta-prompts 'Stop' to alert the participant to process information required for the task, and for errorless learning. Then the OT prompt 'sense/attend, think and do', to more specific behavioural prompts selected by the therapist based on the components from the PRPP Assessment stage 2. At best the skills are generalized throughout all everyday activities, and the OTs' role as a cognitive mediator fades as the person internalize the strategies.
Primary Outcome Measure Information:
Title
Change in task performance
Description
Five everyday tasks will be target behavior, and each will be divided into a series of significant steps and measured in percentage mastery of the steps according to "The Perceive, Recall, Plan and Perform Assessment stage 1" as a functional measure. The highest score is 100% mastery of the steps, and the lowest is 0%, where none of the steps have appropriate mastery. With a score above 85% the participant is considered as independent, but with minor errors in performance.
Time Frame
Is measured at 5 points in each of the 4 phases; in the baseline phase of the 3, 5 or 7 first days after referral to OT, during 3 weeks of intervention phase, the 2 following days as post-intervention, and 4 weeks after discharge to home.
Secondary Outcome Measure Information:
Title
Change in cognitive strategy application
Description
"The Perceive, Recall, Plan and Perform Assessment stage 2" (PRPP) is used to measure the effectiveness of 34 observable cognitive strategy application behaviours in the everyday task performance.The PRPP Assessment stage 2 is criterion-referenced and evaluated in a three-point scale: (3) effective task performance, (2) questionable or (1) not effective. An effective performance in all the observable strategies will give a score of 102 points and with the lowest outcome of 34 points if all the cognitive strategy applications are not effective. For the therapist it will be even more valuable to notice which of the cognitive strategies that are not effective, as a foundation for the intervention.
Time Frame
Is measured at 5 points in each of the 4 phases; in the baseline phase of the 3, 5 or 7 first days after referral to OT, during 3 weeks of intervention phase, the 2 following days as post-intervention, and 4 weeks after discharge to home.
Other Pre-specified Outcome Measures:
Title
Change in the Barthel Index
Description
The Barthel Index assess functional outcomes to measure independency in daily activities and will serve as generalization measures for the target behavior. The Barthel Index quantify the participants' performance in 10 activities of daily life, where the participants can be scored for 0, 5 or 10 points, with the highest score of 100 is the highest value and a score over 95 consider that the participant is independent in personal daily activities. A score of 0 is the lowest value and worse outcome.
Time Frame
Is measured all together three times, once in the baseline phase of 3, 5 or 7 days, the 2 following days after 3 weeks of the intervention phase in the post-intervention phase and after 4 weeks after discharge in a follow-up phase.
Title
Change in the Goal Attainment Scale
Description
The Goal Attainment Scale is a method of quantifying the extent to which patient's individual goals are achieved in the course of intervention. The scores goes from -2, -1, 0, +1 and +2. The score of 0 is the baseline value, and better outcome is the scores of +1 and +2, whereas worse outcome is the -1 and -2 scores.
Time Frame
Is measured all together three times, once in the baseline phase of 3, 5 or 7 days, the 2 following days after 3 weeks of the intervention phase in the post-intervention phase and after 4 weeks after discharge in a follow-up phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission to the health centres in the two municipalities Acquired brain injury Mastery under 85% of PRPP Assessment stage 1 Exclusion Criteria: An already diagnosed dementia or progressive brain disorder Congenital brain injury or neurological developmental disorder Not able to understand or hear instructions, due to foreign language, severe hearing loss or severe arousal problems Physical disabilities that hinder performance of most daily activities. If a participant show mastery above 85% of PRPP Assessment stage 1, the participant either need to be assessed in more taxonomic difficult activities or will be excluded with 'no cognitive challenges in occupational performance'.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marte Ørud Lindstad
Phone
0047-99592692
Email
marte.lindstad@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Stigen, PhD
Phone
0047-93223019
Email
linda.stigen@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Vifladt
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Østre Toten Municipality, Department of Physio- and Occupational Therapy
City
Lena
ZIP/Postal Code
2850
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marte Ørud Lindstad
Phone
0047-99592692
Email
marte.lindstad@ntnu.no
First Name & Middle Initial & Last Name & Degree
Kristin Jess-Bakken
Phone
0047-468 58 549
Email
Kristin.Jess-Bakken@ototen.no
Facility Name
Skien Municipality, Department of Rehabilitation and Palliative Care
City
Skien
ZIP/Postal Code
3717
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marte Ørud Lindstad
Phone
0047-99592692
Email
marte.lindstad@ntnu.no
First Name & Middle Initial & Last Name & Degree
Marit Ro
Phone
0047-40907023
Email
marit.ro@skien.kommune.no

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data Sharing Plan: The results of this project will be shared in scientific journals and clinical and scientific conferences. The research data will be used by the Project Manager, the PhD Candidate and students supervised by them until five years after the project ends (probably year 2029). After that, any data will be deidentified, and personal information will be deleted. Regarding the approval from the Regional Ethics Committee (REC, project number 215391) and the participant consent, data sharing with other research groups is not prepared for and planned. However, anonymized raw data generated with PRPP stages 1 and 2, The Goal Attainment Scaling and The Barthel Index are available upon reasonable request and can be used for purposes mentioned in the REC approval and participant consent. The data are in Norwegian, and a translation is not planned.
IPD Sharing Time Frame
See plan description.
IPD Sharing Access Criteria
Upon reasonable request to the Project Manager Dr. Linda Stigen.
Citations:
PubMed Identifier
32107202
Citation
Porcino AJ, Shamseer L, Chan AW, Kravitz RL, Orkin A, Punja S, Ravaud P, Schmid CH, Vohra S; SPENT group. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ. 2020 Feb 27;368:m122. doi: 10.1136/bmj.m122. No abstract available.
Results Reference
background
PubMed Identifier
27101888
Citation
Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. J Clin Epidemiol. 2016 May;73:142-52. doi: 10.1016/j.jclinepi.2016.04.006. Epub 2016 Apr 19.
Results Reference
background
PubMed Identifier
36198473
Citation
Lindstad MO, Obstfelder AU, Sveen U, Stigen L. Effectiveness of the Perceive, Recall, Plan and Perform intervention for persons with brain injury in community-based rehabilitation: protocol for a single-case experimental design with multiple baselines. BMJ Open. 2022 Oct 5;12(10):e060206. doi: 10.1136/bmjopen-2021-060206.
Results Reference
derived

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Occupational Therapy and Cognitive Challenges After Brain Injury

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