Chronic Obstructive Pulmonary DiseaseNCT04127383
Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool
A study testing Assessment of Burden of Chronic Conditions (ABCC)-tool in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Maastricht University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Diabetes Mellitus, Type 2
- What is being tested?
- Assessment of Burden of Chronic Conditions (ABCC)-tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2019to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis COPD, asthma, Diabetes Mellitus type 2 and/or heart failure
- can understand and read the Dutch language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Assessment of Burden of Chronic Conditions (ABCC)-tool
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 months (baseline), 18 months
Secondary outcomes (7)
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
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.
Measured: 0 months (baseline), 6 months, 12 months
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
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.
Measured: 0 months (baseline), 18 months
Quality of life (EQ-5D-5L)
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.
Measured: 0 months (baseline), 6 months, 12 months, 18 months
Capability well-being (ICECAP-A)
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
Measured: 0 months (baseline), 6 months, 12 months, 18 months
Patients' activation (PAM)
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.
Measured: 0 months (baseline), 6 months, 12 months, 18 months
Medical Consumption within Health Care
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.
Measured: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
Productivity losses
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.
Measured: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Nov 2019
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic clustered quasi-experimental study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Instititute for Health Services Research, TNO, University of Twente
- Responsible party
- Principal investigator, Esther Boudewijns, Maastricht University
- Investigators
- Onno CP van Schayck, Prof., Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127383
- Sponsor's protocol ID
- 10-10400-98-001
- Status last verified
- Mar 2023
- First submitted
- 10 Oct 2019
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data can be shared with researchers who provide a methodologically sound proposal.
Publications
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.
PubMed 40555443Boudewijns 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.
PubMed 38738695Boudewijns 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.
PubMed 33203626
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04127383
- Acronym / sponsor ID
- 10-10400-98-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Netherlands Instititute for Health Services Research, TNO, University of Twente
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic clustered quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| ABCC-tool | Experimental | Device: Assessment of Burden of Chronic Conditions (ABCC)-toolThe 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. |
| Usual care | No intervention | –The control group will receive usual care, and healthcare providers will not be instructed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis COPD, asthma, Diabetes Mellitus type 2 and/or heart failure
- can understand and read the Dutch language
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Burden of Chronic Conditions (ABCC)-toolThe 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. | Device | ABCC-tool |
Primary outcome
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.
7 secondary outcomes
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care
Time frame: 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
Quality of life (EQ-5D-5L)
Time frame: 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
Patients' activation (PAM)
Time frame: 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
Productivity losses
Time frame: 0 (baseline), 3, 6, 9, 12, 15 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 40555443Peters 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.
- Derived from this study: PubMed 38738695Boudewijns 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.
- Derived from this study: PubMed 33203626Boudewijns 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual data can be shared with researchers who provide a methodologically sound proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onno CP van Schayck, Prof. study director
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of Burden of Chronic Conditions (ABCC)-tool in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived quality of care (PACIC): Patient Assessment of Chronic Illness Care (time frame: 0 months (baseline), 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.