--- title: Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool nct_id: NCT04127383 overall_status: COMPLETED phase: NA sponsor: Maastricht University study_type: INTERVENTIONAL primary_condition: Chronic Obstructive Pulmonary Disease countries: Netherlands canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04127383.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04127383" ct_last_update_post_date: 2023-03-16 last_seen_at: "2026-05-12T06:20:15.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Effectiveness and Implementation of the Assessment of Burden of Chronic Conditions (ABCC)-Tool **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 **NCT ID:** [NCT04127383](https://clinicaltrials.gov/study/NCT04127383) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 237 - **Lead Sponsor:** Maastricht University - **Collaborators:** Netherlands Instititute for Health Services Research, TNO, University of Twente - **Conditions:** Chronic Obstructive Pulmonary Disease, Asthma, Diabetes Mellitus, Type 2, Heart Failure - **Start Date:** 2019-11-01 - **Completion Date:** 2022-11-01 - **CT.gov Last Update:** 2023-03-16 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **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. - **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)-tool** (DEVICE) — 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. ## Primary Outcomes - **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. ## 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)_ ## Locations (1) - Maastricht University, Maastricht, Limburg, Netherlands ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.maastricht university|maastricht|limburg|netherlands` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04127383.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04127383* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*