A Better Everyday Life 1.0 - a Protocol for a Feasibility Study

Activities of Daily Living Clinical Trial

Official title:

Evaluation of the Occupational Therapy Intervention Program "A Better Everyday Life 1.0" - a Protocol for a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335709
• Other study ID #: EW1
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: February 12, 2018

Study information

• Verified date: September 2019
• Source: Parker Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate a) the feasibility and b) the potential outcomes of a first version of an occupational therapy intervention program aiming at enhancing the ability to perform activities of daily living (ADL) among persons living with chronic conditions.

In the study a pre-post test design is applied.

Description:

Introduction

Existing research has revealed that persons with chronic conditions experience decreased ability to perform both Personal ADL (PADL) and Instrumental ADL (IADL) tasks. Persons living with a chronic condition are offered various interventions. Besides medical treatment provided by physicians, to prevent or treat symptoms, persons with chronic diseases are often offered physical exercise in order to improve physical and/or mental body functions. Such interventions are founded on a belief that enhanced physical and mental body functioning also will result in improved ability to perform ADL tasks. However, existing research indicate that improvements in body functions not necessarily translate into improved ADL ability.

Research investigating the outcomes of rehabilitation services designed to enhance occupational performance, including ADL task performance, is sparse and insufficient. Existing research within this area is characterized by diversity and methodological limitations preventing development of clear intervention guidelines for clinical practice. Therefore, an occupational therapy program directly aiming at enhancing the ADL ability in persons with chronic conditions.

Aim

The purpose of this study is to evaluate a) the feasibility and b) the potential outcomes of a first version of an occupational therapy intervention program aiming at enhancing the ability to perform activities of daily living (ADL) among persons living with chronic conditions.

Methods

In the study a pre-test - post-test design is applied. That is, 30 participants living with chronic conditions are assigned to an eight week occupational therapy intervention program.

Outcome measures are self-reported and observed ADL ability measured using the ADL-Interview (ADL-I) and the Assessment of Motor and Process Skills (AMPS). Furthermore, various registrations (made by occupational therapists and participants) related to the feasibility of the intervention will be collected and analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years

• diagnosed (by a physician) with one or more chronic condition(s)

• has participated in one or more the rehabilitation program at the municipality

• is living at home

• is experiencing problems related to performance of ADL tasks and is motivated to participate in the ADL intervention .

Exclusion Criteria:

• substance abuse

• other acute diagnoses affecting ADL task performance

• language barriers causing problems related to understanding Danish or participating in the program.

Related Conditions & MeSH terms

• Activities of Daily Living

Intervention

Behavioral:
• ADL intervention
Overall, an adaptational approach is being applied. The intervention sessions include changes related to the person, the environment and/or the occupation.

Locations

Country	Name	City	State
Denmark	Municipality of Mariagerfjord	Hadsund

Sponsors (4)

Lead Sponsor	Collaborator
Parker Research Institute	Municipality of Mariagerfjord, Denmark, University College of Northern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Motor and Process Skills (AMPS)	The Assessment of Motor and Process Skills (AMPS) is a standardized observation-based evaluation tool used by occupational therapists to measure a person's observed quality of ADL task performance in terms of physical effort and/or fatigue, efficiency, safety and independence. After the observation the quality of each skill is evaluated on a four point ordinal scale according to the scoring criteria in the AMPS manual.; The available AMPS software, based on Many-Faceted Rasch statistics, makes it possible to convert ordinal raw scores into overall linear ADL motor and ADL process ability measures adjusted for task challenge, skill item difficulty and rater severity. The measures are expressed in logits (log-odds probability units).	Change from baseline at eight weeks.
Primary	ADL-Interview (ADL-I)	The ADL-Interview (ADL-I) is developed to describe and measure the ADL ability based on self-report. Using the ADL-I, the participant is asked to report their perceived ADL ability (i.e. quality of ADL task performance) for each of the 47 ADL items using seven response categories.; Data will be used to (a) describe the self-reported quality of ADL task performance on each task for a single person or a group of people and (b) measure a single person's overall self-reported quality of ADL task performance. To create an overall measure of self-reported quality of ADL task performance Rasch measurement methods are applied in order to transform the ratings into an overall linear (interval scale) measure of self-reported quality of ADL task performance, adjusted for the difficulty of the ADL task.	Change from baseline at eight weeks.