Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool

March 14, 2023 updated by: Esther Boudewijns, Maastricht University

Effectiveness, Cost-effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool in Patients With COPD, Asthma, Diabetes Mellitus Type 2 and Heart Failure: a Pragmatic Clustered Quasi-experimental Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
237

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200MD
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ABCC-tool
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
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.
No Intervention: Usual care
The control group will receive usual care, and healthcare providers will not be instructed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
Time Frame: 0 months (baseline), 18 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
Time Frame: 0 months (baseline), 6 months, 12 months
Measured with the Patient Assessment of Chronic Illness Care, for total group and for each condition separately. 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), 6 months, 12 months
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
Time Frame: 0 months (baseline), 18 months
Measured with the Patient Assessment of Chronic Illness Care, for each condition separately. 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
Quality of life (EQ-5D-5L)
Time Frame: 0 months (baseline), 6 months, 12 months, 18 months
Measured with the EuroQol-5D-5L, for total group and for each condition separately. The scale consists of the EQ-5D-5L descriptive system with 5 questions, and a VAS-scale. Answers range from 1 (best) to 5 (worst). EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, will be converted into a single index value (Dutch values). The EQ-5D-5L VAS will also be determined.
0 months (baseline), 6 months, 12 months, 18 months
Capability well-being (ICECAP-A)
Time Frame: 0 months (baseline), 6 months, 12 months, 18 months
Measured with the ICEpop CAPability measure for Adults, for total group and for each condition separately. The questionnaire consists of 5 questions. Answers range from 1 (no capability) to 4 (full capability for an attribute). A tariff value for an overall state can be calculated by summing the values across the individual attributes. This code will allow calculation of ICECAP-A tariffs for each respondent in a study
0 months (baseline), 6 months, 12 months, 18 months
Patients' activation (PAM)
Time Frame: 0 months (baseline), 6 months, 12 months, 18 months
Measured with the Patient Activation Measure, for total group and for each condition separately. The questionnaire consists of 13 questions on a 5-point scale. The scores range from 0 to 100. The higher the score, the more capable a person is in self-management.
0 months (baseline), 6 months, 12 months, 18 months
Medical Consumption within Health Care
Time Frame: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
Measured with the Medical Consumption Questionnaire (MCQ), for total group and for each condition separately. The questionnaire includes 16 questions related to frequently occurring contacts with health care providers. The items will be valued using standard cost prices in the Netherlands. The costs of medical consumption are calculated by multiplying the volumes of care by the cost per unit of care. This will be used for a cost-effectiveness analysis.
0 (baseline), 3, 6, 9, 12, 15 and 18 months
Productivity losses
Time Frame: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
Measured with the Productivity Costs Questionnaire (PCQ), for total group and for each condition separately. The questionnaire includes 9 questions related to the impact of disease on the ability of a person to perform work. The items will be valued using standard cost prices in the Netherlands. Productivity lossess are calculated by multiplying the volumes by cost prices per unit. This will be used for a cost-effectiveness analysis.
0 (baseline), 3, 6, 9, 12, 15 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TNO
Netherlands Instititute for Health Services Research
University of Twente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Onno CP van Schayck, Prof., Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-10400-98-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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