NCT04127383

Brief Summary

This study is designed to evaluate the effectiveness and implementation of the Assessment of Burden of Chronic Conditions (ABCC)-tool for patients with COPD, asthma, diabetes mellitus type 2 or heart failure (and any combination of these conditions) in real-life routine practice. The ABCC-tool consists of a questionnaire, a visualisation using balloons that is based on cut-off points, and treatment advice. The ABCC-tool is intended to be used in daily healthcare practice, is designed to monitor a patient's integrated health status over time, to facilitate shared decision making, and to stimulate self-management. The study has a pragmatic clustered quasi-experimental design with two arms. The intervention group will use the ABCC-tool and the control group will receive usual care. The study will be implemented at a general practice-level, and has a follow-up period of 18 months. The primary outcome is change in perceived quality of care, as measured with the Patient Assessment of Chronic Illness Care (PACIC), as compared to usual care after 18 months. It is hypothesized that the change in perceived quality of care is significantly higher in the group using the ABCC-tool as compared to the group that receives usual care. Additionally the implementation of the ABCC-tool in general practices will be evaluated in 12 general practices. The implementation study will evaluate the context of caregivers with the Consolidated Framework for Implementation Research, the process of implementation with the RE-AIM framework, and fidelity to the intervention with the fidelity framework.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

October 10, 2019

Last Update Submit

March 14, 2023

Conditions

Chronic Obstructive Pulmonary DiseaseAsthmaDiabetes Mellitus, Type 2Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care

    Measured with the Patient Assessment of Chronic Illness Care, for total group. The scale has 20 items. Answers range from 1 to 5. Average scores (range 1-5) will be calculated. Higher scores mean more frequent presence of the aspect of structured chronic care.

    0 months (baseline), 18 months

Secondary Outcomes (7)

  • Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care

    0 months (baseline), 6 months, 12 months

  • Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care

    0 months (baseline), 18 months

  • Quality of life (EQ-5D-5L)

    0 months (baseline), 6 months, 12 months, 18 months

  • Capability well-being (ICECAP-A)

    0 months (baseline), 6 months, 12 months, 18 months

  • Patients' activation (PAM)

    0 months (baseline), 6 months, 12 months, 18 months

  • +2 more secondary outcomes

Study Arms (2)

ABCC-tool

EXPERIMENTAL

The intervention group will use the ABCC-tool during consultation with their healthcare provider. Healthcare providers in the intervention group will receive a short instructional film about the ABCC-tool before the start of the study. Additionally, healthcare providers from 12 practices will be invited for interviews, evaluating the context and process of implementation.

Device: Assessment of Burden of Chronic Conditions (ABCC)-tool

Usual care

NO INTERVENTION

The control group will receive usual care, and healthcare providers will not be instructed

Interventions

Assessment of Burden of Chronic Conditions (ABCC)-toolDEVICE

The tool consists of a questionnaire, a visualisation using balloons, and treatment advice. A patient completes the questionnaire before consultation. The questionnaire measures the experienced burden of the chronic condition(s), and several risk factors. The questionnaire consists of a generic part and disease-specific parts. The generic questionnaire will be combined with any amount of disease-specific questionnaires (i.e. COPD, asthma, diabetes type 2 and heart failure), to form a single personalised scale and balloon chart for each individual patient. Outcomes of the questionnaire are visualised using balloons. The healthcare provider opens the visualisation during consultation. A balloon represents a domain, and the colour and height indicate a score on that domain. If a patient and healthcare provider select a balloon by clicking on it, treatment advice is shown by means of pop-ups. Based on the discussion following treatment advice, personal care plans can be determined.

ABCC-tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis COPD, asthma, Diabetes Mellitus type 2 and/or heart failure
  • can understand and read the Dutch language

You may not qualify if:

  • COPD or asthma: used prednisone due to an exacerbation less than six weeks ago
  • Heart failure or diabetes mellitus type 2: hospitalized less than six weeks ago
  • Healthcare providers or patients who have already used the Assessment of Burden of COPD-tool are excluded from the control group
  • Patients who have already used the Assessment of Burden of COPD-tool will be excluded from the intervention group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200MD, Netherlands

Location

Related Publications (3)

  • Peters LH, Joore MA, Gidding-Slok AH, Keijsers LC, Twellaar M, Boudewijns EA, van Schayck OC, Muris JW, Kimman ML. Cost-effectiveness analysis of the Assessment of Burden of Chronic Conditions (ABCC) tool in primary care in the Netherlands. BMJ Open. 2025 Jun 24;15(6):e099762. doi: 10.1136/bmjopen-2025-099762.

    PMID: 40555443DERIVED

  • Boudewijns EA, Claessens D, van Schayck OCP, Twellaar M, Winkens B, Joore MA, Keijsers LCEM, Krol S, Urlings M, Gidding-Slok AHM. Effectiveness of the Assessment of Burden of Chronic Conditions (ABCC)-tool in patients with asthma, COPD, type 2 diabetes mellitus, and heart failure: A pragmatic clustered quasi-experimental study in the Netherlands. Eur J Gen Pract. 2024 Dec;30(1):2343364. doi: 10.1080/13814788.2024.2343364. Epub 2024 May 13.

    PMID: 38738695DERIVED

  • Boudewijns EA, Claessens D, Joore M, Keijsers LCEM, van Schayck OCP, Winkens B, Gidding-Slok AHM. Effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in patients with COPD, asthma, diabetes mellitus type 2 and heart failure: protocol for a pragmatic clustered quasi-experimental study. BMJ Open. 2020 Nov 17;10(11):e037693. doi: 10.1136/bmjopen-2020-037693.

    PMID: 33203626DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthmaDiabetes Mellitus, Type 2Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Onno CP van Schayck, Prof.

    Maastricht University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of healthcare providers and patients is not possible due to the nature of the intervention, but the study team will be blind to treatment arms in the data set during data cleaning, handling of missing data, statistical analyses and drawing of conclusions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic clustered quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 15, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Deidentified individual data can be shared with researchers who provide a methodologically sound proposal.

Locations

NL(1)