- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04127383
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
237
Phase
- 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
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Limburg
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Maastricht, Limburg, Netherlands, 6200MD
- Maastricht University
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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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
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No Intervention: Usual care
The control group will receive usual care, and healthcare providers will not be instructed
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What is the study measuring?
Primary Outcome Measures
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
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.
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0 months (baseline), 6 months, 12 months, 18 months
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Capability well-being (ICECAP-A)
Time Frame: 0 months (baseline), 6 months, 12 months, 18 months
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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
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0 months (baseline), 6 months, 12 months, 18 months
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Patients' activation (PAM)
Time Frame: 0 months (baseline), 6 months, 12 months, 18 months
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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.
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0 months (baseline), 6 months, 12 months, 18 months
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Medical Consumption within Health Care
Time Frame: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
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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.
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0 (baseline), 3, 6, 9, 12, 15 and 18 months
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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.
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0 (baseline), 3, 6, 9, 12, 15 and 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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.
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)
November 1, 2019
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
October 10, 2019
First Submitted That Met QC Criteria
October 14, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Endocrine System Diseases
- Bronchial Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Heart Failure
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Asthma
Other Study ID 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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