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

NCT ID: NCT03335709

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-04
• Study Completion Date: 2018-02-12

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.

Detailed 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.

Conditions

Activities of Daily Living

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADL intervention

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)

Group Type: EXPERIMENTAL

ADL intervention

Intervention Type: BEHAVIORAL

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

Interventions

ADL intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College of Northern Denmark

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Municipality of Mariagerfjord, Denmark

UNKNOWN

Sponsor Role: collaborator

Parker Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Eva Ejlersen Wæhrens

OT, PhD and senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva E Wæhrens, PhD

Role: PRINCIPAL_INVESTIGATOR

The Parker Institute

Locations

Municipality of Mariagerfjord

Hadsund, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 33602338 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29780029 (View on PubMed)

Other Identifiers

EW1

Identifier Type: -

Identifier Source: org_study_id