An interventional study of The Perceive, Recall, Plan and Perform System of Intervention in Brain Injuries and Cognitive Impairment, sponsored by Norwegian University of Science and Technology. Completed at 2 sites in Norway. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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.
2,125 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 6 is below the median of 48 across 1,341 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Norwegian University of Science and Technology is the lead sponsor of 494 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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.
Also known as: PRPP
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.
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.
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.
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.
Change in the Barthel Index
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.
Change in the Goal Attainment Scale
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.
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: See plan description.
Access criteria: Upon reasonable request to the Project Manager Dr. Linda Stigen.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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