Occupational Therapy and Cognitive Challenges After Brain Injury

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT05148247
Collaborator
Østre Toten Municipality (Other), Skien Municipality (Other)
6
2
1
20.1
3
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The Perceive, Recall, Plan and Perform System of Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 28, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRPP Intervention

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.

Behavioral: The Perceive, Recall, Plan and Perform System of Intervention
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.
Other Names:
  • PRPP
  • Outcome Measures

    Primary Outcome Measures

    1. Change in task performance [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.]

      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

    1. Change in cognitive strategy application [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.]

      "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.

    Other Outcome Measures

    1. Change in the Barthel Index [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.]

      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.

    2. Change in the Goal Attainment Scale [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.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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'.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Østre Toten Municipality, Department of Physio- and Occupational Therapy Lena Norway 2850
    2 Skien Municipality, Department of Rehabilitation and Palliative Care Skien Norway 3717

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • Østre Toten Municipality
    • Skien Municipality

    Investigators

    • Study Chair: Heidi Vifladt, Norwegian University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT05148247
    Other Study ID Numbers:
    • REK 215391
    First Posted:
    Dec 8, 2021
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norwegian University of Science and Technology
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 4, 2022