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

NCT03335709 | Completed

• 1 other identifier: EW1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Activities of Daily Living

Keywords

Occupational therapy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

ADL intervention

EXPERIMENTAL

The participants are assigned to an eight-week intervention program aiming at enhancing ADL ability. The program consists of a minimum of five and a maximum of eight sessions; Session one - First meeting and occupational therapy evaluation (mandatory), Session two - Goal setting and clarifying reasons for problems related to ADL (mandatory), Session three- seven - Interventions aiming at enhancing ADL ability (Number of sessions can vary. However, a minimum of two sessions are mandatory), Session eight - Re-evaluation (Mandatory)

Behavioral: ADL intervention

Interventions

ADL intervention BEHAVIORAL

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

ADL intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• substance abuse
• other acute diagnoses affecting ADL task performance
• language barriers causing problems related to understanding Danish or participating in the program.

Sponsors & Collaborators

• Parker Research Institute: lead
• University College of Northern Denmark: collaborator
• University of Southern Denmark: collaborator
• Municipality of Mariagerfjord, Denmark: collaborator

Study Sites (1)

Municipality of Mariagerfjord

Hadsund, 9560, Denmark

Location

Related Publications (2)

• Nielsen KT, Guidetti S, von Bulow C, Klokker L, Waehrens EE. Feasibility of ABLE 1.0-a program aiming at enhancing the ability to perform activities of daily living in persons with chronic conditions. Pilot Feasibility Stud. 2021 Feb 18;7(1):52. doi: 10.1186/s40814-021-00790-7.

  PMID: 33602338 DERIVED

• Guidetti S, Nielsen KT, von Bulow C, Pilegaard MS, Klokker L, Waehrens EE. Evaluation of an intervention programme addressing ability to perform activities of daily living among persons with chronic conditions: study protocol for a feasibility trial (ABLE). BMJ Open. 2018 May 20;8(5):e020812. doi: 10.1136/bmjopen-2017-020812.

  PMID: 29780029 DERIVED

Study Officials

• Eva E Wæhrens, PhD

  The Parker Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OT, PhD and senior researcher

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: November 8, 2017
• Study Start: September 4, 2017
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

DK (1)