Chronic Kidney Disease(CKD)ImpsoNCT06807567
Acceptability and Feasibility of Interventions for Integrated Care of Chronic Kidney Disease With Other Long-term Health Conditions in Malawi: a Qualitative Study
An observational study of Chronic Kidney Disease(CKD) and Multimorbidity, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
The burden of chronic kidney disease (CKD) is rising globally, but disproportionately impacting on low- and middle-income countries (LMIC) including Malawi, which have the fewest resources to manage it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD), Multimorbidity, Long-term Health Conditions
- What is being tested?
- Receipt of healthcare for long-term conditions, Provision of healthcare and Policy making
- How many people
- 60 participants
- Where
- 1 siteMalawi
- Study dates
- 17 Feb 2025to 5 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: - We will recruit adults aged 18 years and older from the following stakeholder groups: * Patients * Caregivers * Healthcare workers (HCWs) * Policy makers Patients will be adults with, or at risk of, CKD and at least one other long-term health condition, who receive outpatient care at Queen Elizabeth Central Hospital (QECH) in Blantyre, Chiradzulu District Hospital or primary health centres within Chiradzulu district. * Caregivers of patients from meeting eligibility criteria will also be invited to participate, if they are identified by the patient to be their primary caregiver. * Healthcare workers (HCWs) will be recruited from amongst staff working at any of the named study locations, whose role involves caring for patients with CKD and/or other long-term health conditions. * Policy makers will be individuals with leading roles in planning, managing and implementing services and policies for non-communicable diseases and/or other long-term conditions in Malawi
Who may be able to join
- Eligibility criteria for each of the participant groups described above are as follows:
- Patients:
- Adults aged ≥ 18 years
- Diagnosed with CKD, or at risk of CKD, AND at least one other long-term health condition out of:
- Hypertension
- Diabetes mellitus
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- HIV infection
- Heart failure
- Stroke (See Table 1 for diagnostic inclusion criteria for each of the above conditions)
- Receiving outpatient care at one of the selected study sites, for at least 6 months
- Caregivers:
- Adults aged ≥ 18 years
- Identified by a patient meeting the above inclusion criteria to be their primary caregiver
- Healthcare workers:
- Adults aged ≥ 18 years
- Currently employed as a healthcare worker at either QECH, Chiradzulu District Hospital, Ndunde Health Centre or Namadzi Health Centre.
- Working in an outpatient clinic environments where care is delivered for patients with any of the above conditions, which may include (but is not limited to) the following:
- CKD clinic (QECH)
- Hypertension clinic (QECH)
- Diabetes clinic (QECH)
- HIV clinic (all study locations, including the Lighthouse clinic at QECH)
- Cardiology /chest clinic (QECH)
- General non-communicable disease (Chiradzulu District Hospital and its referring primary health centres)
- Policy makers
- Adults aged ≥ 18 years
- Identified through stakeholder mapping and/or snowball sampling to have a leading role relevant to planning, managing and implementing services and/or policies for NCDs and/or other LTCs.
Who cannot join
- • Under 18 years of age
- Acute physical or mental illness, which requires urgent treatment and might impact on ability to participate in and complete interview
- Current hospital inpatient
- Unable to participate in interview due to severe communication difficulties (e.g. aphasia), confusion or behavioural disturbance
- Declines consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site
Malawi Liverpool Wellcome Clinical Research Programme
Blantyre
Brian Ngwira, +265 993888275, bngwira@mlw.mw
Charlotte M Snead, charlotte.snead@lstmed.ac.uk
About this study
Official title: Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi to Inform Interventions for Earlier Detection ad Prevention (Impso Study)
The burden of chronic kidney disease (CKD) is rising globally, but disproportionately impacting on low- and middle-income countries (LMIC) including Malawi, which have the fewest resources to manage it. Furthermore, CKD is the leading cause of catastrophic health expenditure worldwide, largely due to the extremely high costs of kidney replacement therapy (KRT) for people with kidney failure. Access to KRT remains limited in many settings, including Malawi, where there is only one nephrologist for a population of over 21 million. It is therefore essential to diagnose and treat CKD in its early stages, to facilitate earlier and more cost-effective treatment to prevent its progression to advanced disease which is associated with increased risks of kidney failure and of cardiovascular morbidity and mortality. CKD is usually asymptomatic in its early stages, so early diagnosis and treatments requires access to key diagnostic tests, in addition to strategies for channelling resources to those at the highest risk.
The causes of CKD are diverse, particularly in LMIC settings where the increasing prevalence of non-communicable diseases intersects with ongoing high burdens of infectious diseases, malnutrition, and many other social and environmental determinants of kidney health. The World Health Organization recommends integrated approaches to improve equity of quality care for people living with long-term conditions, and CKD would be amenable to integrated approaches, however CKD has been neglected from global NCD agendas and there is little data to guide the most effective methods for integrating its care with other long-term conditions (such as hypertension, diabetes and HIV infection), particularly in low-income settings such as Malawi.
The aim of this study is to explore current experiences of care for CKD and related long-term conditions, and to qualitatively evaluate the acceptability and feasibility of different potential approaches to integrating their care, amongst different stakeholders groups in Malawi.
- Being tested
- Receipt of healthcare for long-term conditions, Provision of healthcare, Policy making
- Keywords
- integrated care, chronic kidney disease, long-term conditions, qualitative research, Malawi
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receipt of healthcare for long-term conditionsOther
The patient participants are people who are already receiving healthcare for CKD and/or hypertension, diabetes, HIV, heart failure and/or stroke at one of the named study sites, for at least 6 months prior to recruitment into this qualitative study. The caregiver participants are caregivers for patients meeting these criteria.
Provision of healthcareOther
The healthcare worker participants are all providing care to patients with long-tem conditions, at one of the names study sites
Policy makingOther
The policy makers recruited to this study will be individuals involved in policy making for long-term conditions in Malawi
| Study group | Role | What they receive |
|---|---|---|
| Patients and caregivers | Patients aged 18 years and over with CKD, or at risk of CKD, who have at least one other long-term condition, and who are receiving care at either Queen Elizabeth Central Hospital in Blantyre, Chiradzulu District Hospital, Namadzi or Ndunde primary health care centres. Caregivers will be the caregivers of patients meeting these conditions. Receives: Other: Receipt of healthcare for long-term conditions | |
| Healthcare workers | Healthcare workers, aged 18 years and over, providing care for patients with CKD and other long-term health conditions at Queen Elizabeth Central Hospital in Blantyre, Chiradzulu District Hospital, Namadzi or Ndunde primary health care centres. Receives: Other: Provision of healthcare | |
| Policy makers | Policy makers with roles in policy making related to CKD and other long-term health conditions in Malawi. Receives: Other: Policy making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Codes and themes
The outcomes of this study will be the codes and themes identified through thematic analysis of the interview and focus group discussion transcripts.
Measured: 6 months from end of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start17 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust (Liverpool Clinical PhD Programme)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807567
- Sponsor's protocol ID
- 24-057
- Acronym
- Impso
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access may be granted to pseudonymised interview transcripts to approved researchers for the purposes of secondary analyses, only following completion of the analysis and subject to approval by the Malawi Liverpool Wellcome Programme (MLW) research strategy group.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi to Inform Interventions for Earlier Detection ad Prevention (Impso Study)
- ClinicalTrials.gov ID
- NCT06807567
- Acronym / sponsor ID
- Impso / 24-057
- Keywords
- integrated care, chronic kidney disease, long-term conditions, qualitative research, Malawi
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Wellcome Trust (Liverpool Clinical PhD Programme)
- Study start
- 17 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 4 Feb 2025 (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.
The burden of chronic kidney disease (CKD) is rising globally, but disproportionately impacting on low- and middle-income countries (LMIC) including Malawi, which have the fewest resources to manage it. Furthermore, CKD is the leading cause of catastrophic health expenditure worldwide, largely due to the extremely high costs of kidney replacement therapy (KRT) for people with kidney failure. Access to KRT remains limited in many settings, including Malawi, where there is only one nephrologist for a population of over 21 million. It is therefore essential to diagnose and treat CKD in its early stages, to facilitate earlier and more cost-effective treatment to prevent its progression to advanced disease which is associated with increased risks of kidney failure and of cardiovascular morbidity and mortality. CKD is usually asymptomatic in its early stages, so early diagnosis and treatments requires access to key diagnostic tests, in addition to strategies for channelling resources to those at the highest risk.
The causes of CKD are diverse, particularly in LMIC settings where the increasing prevalence of non-communicable diseases intersects with ongoing high burdens of infectious diseases, malnutrition, and many other social and environmental determinants of kidney health. The World Health Organization recommends integrated approaches to improve equity of quality care for people living with long-term conditions, and CKD would be amenable to integrated approaches, however CKD has been neglected from global NCD agendas and there is little data to guide the most effective methods for integrating its care with other long-term conditions (such as hypertension, diabetes and HIV infection), particularly in low-income settings such as Malawi.
The aim of this study is to explore current experiences of care for CKD and related long-term conditions, and to qualitatively evaluate the acceptability and feasibility of different potential approaches to integrating their care, amongst different stakeholders groups in Malawi.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients and caregivers | – | Other: Receipt of healthcare for long-term conditionsPatients aged 18 years and over with CKD, or at risk of CKD, who have at least one other long-term condition, and who are receiving care at either Queen Elizabeth Central Hospital in Blantyre, Chiradzulu District Hospital, Namadzi or Ndunde primary health care centres. Caregivers will be the caregivers of patients meeting these conditions. |
| Healthcare workers | – | Other: Provision of healthcareHealthcare workers, aged 18 years and over, providing care for patients with CKD and other long-term health conditions at Queen Elizabeth Central Hospital in Blantyre, Chiradzulu District Hospital, Namadzi or Ndunde primary health care centres. |
| Policy makers | – | Other: Policy makingPolicy makers with roles in policy making related to CKD and other long-term health conditions in Malawi. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - We will recruit adults aged 18 years and older from the following stakeholder groups: * Patients * Caregivers * Healthcare workers (HCWs) * Policy makers Patients will be adults with, or at risk of, CKD and at least one other long-term health condition, who receive outpatient care at Queen Elizabeth Central Hospital (QECH) in Blantyre, Chiradzulu District Hospital or primary health centres within Chiradzulu district. * Caregivers of patients from meeting eligibility criteria will also be invited to participate, if they are identified by the patient to be their primary caregiver. * Healthcare workers (HCWs) will be recruited from amongst staff working at any of the named study locations, whose role involves caring for patients with CKD and/or other long-term health conditions. * Policy makers will be individuals with leading roles in planning, managing and implementing services and policies for non-communicable diseases and/or other long-term conditions in Malawi
Key inclusion criteria (26 listed)
- Eligibility criteria for each of the participant groups described above are as follows:
- Adults aged ≥ 18 years
- Diagnosed with CKD, or at risk of CKD, AND at least one other long-term health condition out of:
- Receiving outpatient care at one of the selected study sites, for at least 6 months
- Adults aged ≥ 18 years
Key exclusion criteria (5 listed)
- • Under 18 years of age
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 |
|---|---|---|
| Receipt of healthcare for long-term conditionsThe patient participants are people who are already receiving healthcare for CKD and/or hypertension, diabetes, HIV, heart failure and/or stroke at one of the named study sites, for at least 6 months prior to recruitment into this qualitative study. The caregiver participants are caregivers for patients meeting these criteria. | Other | Patients and caregivers |
| Provision of healthcareThe healthcare worker participants are all providing care to patients with long-tem conditions, at one of the names study sites | Other | Healthcare workers |
| Policy makingThe policy makers recruited to this study will be individuals involved in policy making for long-term conditions in Malawi | Other | Policy makers |
Primary outcome
Codes and themes
Time frame: 6 months from end of data collection
The outcomes of this study will be the codes and themes identified through thematic analysis of the interview and focus group discussion transcripts.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Yes. Access may be granted to pseudonymised interview transcripts to approved researchers for the purposes of secondary analyses, only following completion of the analysis and subject to approval by the Malawi Liverpool Wellcome Programme (MLW) research strategy group.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease(CKD) and Multimorbidity, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
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 26 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Feb 2025. 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 Malawi. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Codes and themes (time frame: 6 months from end of data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.