Occupational Therapy and Cognitive Challenges After Brain Injury

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148247
• Other study ID #: REK 215391
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Norwegian University of Science and Technology
• Contact: Marte Ørud Lindstad
• Phone: 0047-99592692
• Email: marte.lindstad[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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'.

Related Conditions & MeSH terms

• Brain Injuries
• Cognitive Dysfunction
• Cognitive Impairment
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Norway	Østre Toten Municipality, Department of Physio- and Occupational Therapy	Lena
Norway	Skien Municipality, Department of Rehabilitation and Palliative Care	Skien

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Østre Toten Municipality, Skien Municipality

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	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.
Other	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.	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.
Primary	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.	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	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.	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.