Rheumatic Heart DiseaseCAMPSNCT05502042
Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease
A study testing Case Manager and Peer Support Group in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial summary
The objective of CAMPS is to test and evaluate scalable models of secondary antibiotic adherence support for children newly diagnosed with rheumatic heart disease. Aim 1: Determine 1-year BPG adherence rates of children newly diagnosed with latent RHD in Uganda randomized to two support strategies: (1) Usual care (Arm… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- Case Manager and Peer Support Group
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUganda
- Study dates
- 15 Aug 2022to 1 Sep 2023
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 5-17
- New diagnosis of latent rheumatic heart disease (RHD) as determined through school screening -
Who cannot join
- Medical contraindication to SAP (bleeding risk, allergy)
- Co-morbid conditions that have already resulted in prescription of SAP (typically HIV, sickle cell disease, renal disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Managers and Peer Support Groups (CAMPS) for Prophylaxis Adherence in Rheumatic Heart Disease
The objective of CAMPS is to test and evaluate scalable models of secondary antibiotic adherence support for children newly diagnosed with rheumatic heart disease.
Aim 1: Determine 1-year BPG adherence rates of children newly diagnosed with latent RHD in Uganda randomized to two support strategies: (1) Usual care (Arm 1) (2) peer group + case manager strategy (Arm 2).
Aim 2: Explore patient reported outcomes including treatment satisfaction, patient health-related quality of life, and care giver quality of life, in relation to support strategy and adherence.
Read the detailed description
While significant strides have been made in echo screening for early detection of RHD and establishment of RHD registries, these efforts are diluted by poor adherence to secondary antibiotic prophylaxis (SAP). In a systematic review by Kevat et al which included 20 global programs, only 20% were able to maintain patients on at least 80% adherence (the minimum acceptable level). Other studies demonstrate similar findings, with adherence ranging from as low as 20% up to 75%. These studies demonstrate that non-adherence undermines most global SAP programs.
Despite low adherence to RHD secondary prophylaxis globally, studies have demonstrated that ideal RHD SAP adherence can be achieved, but within the confines of strict trial conditions (GOAL Trial). Currently, there is a dearth of research into pragmatic, scalable approaches to improve RHD SAP adherence. In their systematic review of effectiveness and integration of RHD prevention and control programs, Abrams et. al. advise that prevention and treatment programs should be integrated into general health systems and strengthen local systems. Case Managers and Peer Support Groups (CAMPS) will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis, integrated into routine care. Hence, CAMPS will address the gap that exists between ideal adherence achieved within the confines of a strict research trial and practical and scalable solutions that can be translated to real-world settings.
- Conditions
- Rheumatic Heart Disease
- Being tested
- Case Manager and Peer Support Group
- Keywords
- adherence, clinical trial, community intervention
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case Manager and Peer Support GroupBehavioural
Assignment of a Village health team member to provide support to the family through SMS messages (weeks 1-3) and phone call (week 4), as well as home visits as needed if no contacts are reached. These contacts are intended to provide encouragement and education to participants and families to encourage SAP and peer group attendance. Peer groups will have simple play and support activities, led by the village health team member, to improve the experience of SAP for the participating children.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Referral to a health facility (HC III, IV, or district hospital) that provide secondary antibiotic prophylaxis (every-28-day intramuscular benzathine benzylpenicillin G, BPG), receipt of a Ministry of Health secondary prophylaxis adherence booklet, and education for patient and family about the importance of SAP. |
| Peer Group + Case Manager | Experimental | Usual care + an assigned village health team member to provide weekly short message (SMS) (weeks 1-3) and phone (week 4) support for attendance of SAP visits and a VHT (village health team member) led peer support group held at the assigned SAP clinic of participants, that includes games/peer support/education. Receives: Behavioral: Case Manager and Peer Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary Prophylaxis Adherence
Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage)
Measured: 12 months
Secondary outcomes (3)
Treatment satisfaction
14-item Abbreviated Treatment Satisfaction Questionnaire (v 1.4)
Measured: 6 months + 12 months
Patient health-related quality of life
Pediatric Quality of Life Inventory Version 4.0 Generic Core (PedsQL 4.0) questionnaire
Measured: enrollment, 6-months, 12-months
Caregiver health-related quality of life
Parent/caregiver module of the PedsQL 4.0
Measured: enrollment, 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start15 Aug 2022
- Primary completion9 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case Managers and Peer Support Groups (CAMPS) will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis, integrated into routine care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute
- Responsible party
- Principal investigator, Sarah deLoizaga Carney, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502042
- Sponsor's protocol ID
- 2021-0789
- Acronym
- CAMPS
- Status last verified
- Jan 2024
- First submitted
- 12 Aug 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available to other investigators on reasonable request after publication of the primary results.
Publications
de Loizaga S, Pulle J, Atanas O, Alepere J, Nambogo JL, Ndagire E, Kaudha G, Ollberding NJ, Okello E, Rwebembera J, Beaton A. Enhanced support for adherence to rheumatic heart disease prophylaxis for children in the public health system in Uganda (CAMPS): a pragmatic randomised trial. Lancet Glob Health. 2025 Apr;13(4):e707-e715. doi: 10.1016/S2214-109X(24)00527-8.
PubMed 40155108
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Managers and Peer Support Groups (CAMPS) for Prophylaxis Adherence in Rheumatic Heart Disease
- ClinicalTrials.gov ID
- NCT05502042
- Acronym / sponsor ID
- CAMPS / 2021-0789
- Conditions
- Rheumatic Heart Disease
- Keywords
- adherence, clinical trial, community intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Uganda Heart Institute
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 16 Aug 2022 (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 objective of CAMPS is to test and evaluate scalable models of secondary antibiotic adherence support for children newly diagnosed with rheumatic heart disease.
Aim 1: Determine 1-year BPG adherence rates of children newly diagnosed with latent RHD in Uganda randomized to two support strategies: (1) Usual care (Arm 1) (2) peer group + case manager strategy (Arm 2).
Aim 2: Explore patient reported outcomes including treatment satisfaction, patient health-related quality of life, and care giver quality of life, in relation to support strategy and adherence.
Detailed description
While significant strides have been made in echo screening for early detection of RHD and establishment of RHD registries, these efforts are diluted by poor adherence to secondary antibiotic prophylaxis (SAP). In a systematic review by Kevat et al which included 20 global programs, only 20% were able to maintain patients on at least 80% adherence (the minimum acceptable level). Other studies demonstrate similar findings, with adherence ranging from as low as 20% up to 75%. These studies demonstrate that non-adherence undermines most global SAP programs.
Despite low adherence to RHD secondary prophylaxis globally, studies have demonstrated that ideal RHD SAP adherence can be achieved, but within the confines of strict trial conditions (GOAL Trial). Currently, there is a dearth of research into pragmatic, scalable approaches to improve RHD SAP adherence. In their systematic review of effectiveness and integration of RHD prevention and control programs, Abrams et. al. advise that prevention and treatment programs should be integrated into general health systems and strengthen local systems. Case Managers and Peer Support Groups (CAMPS) will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis, integrated into routine care. Hence, CAMPS will address the gap that exists between ideal adherence achieved within the confines of a strict research trial and practical and scalable solutions that can be translated to real-world settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Case Managers and Peer Support Groups (CAMPS) will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis, integrated into routine care.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Referral to a health facility (HC III, IV, or district hospital) that provide secondary antibiotic prophylaxis (every-28-day intramuscular benzathine benzylpenicillin G, BPG), receipt of a Ministry of Health secondary prophylaxis adherence booklet, and education for patient and family about the importance of SAP. |
| Peer Group + Case Manager | Experimental | Behavioral: Case Manager and Peer Support GroupUsual care + an assigned village health team member to provide weekly short message (SMS) (weeks 1-3) and phone (week 4) support for attendance of SAP visits and a VHT (village health team member) led peer support group held at the assigned SAP clinic of participants, that includes games/peer support/education. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ages 5-17
- New diagnosis of latent rheumatic heart disease (RHD) as determined through school screening -
Key exclusion criteria (2 listed)
- Medical contraindication to SAP (bleeding risk, allergy)
- Co-morbid conditions that have already resulted in prescription of SAP (typically HIV, sickle cell disease, renal disease)
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 |
|---|---|---|
| Case Manager and Peer Support GroupAssignment of a Village health team member to provide support to the family through SMS messages (weeks 1-3) and phone call (week 4), as well as home visits as needed if no contacts are reached. These contacts are intended to provide encouragement and education to participants and families to encourage SAP and peer group attendance. Peer groups will have simple play and support activities, led by the village health team member, to improve the experience of SAP for the participating children. | Behavioural | Peer Group + Case Manager |
Primary outcome
Secondary Prophylaxis Adherence
Time frame: 12 months
Continuous adherence to intramuscular Benzathine penicillin, as determined by days of coverage (each injection = 28 days of coverage)
3 secondary outcomes
Treatment satisfaction
Time frame: 6 months + 12 months
Patient health-related quality of life
Time frame: enrollment, 6-months, 12-months
Caregiver health-related quality of life
Time frame: enrollment, 6-months, 12-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 18 Jan 2024.
- Derived from this study: PubMed 40155108de Loizaga S, Pulle J, Atanas O, Alepere J, Nambogo JL, Ndagire E, Kaudha G, Ollberding NJ, Okello E, Rwebembera J, Beaton A. Enhanced support for adherence to rheumatic heart disease prophylaxis for children in the public health system in Uganda (CAMPS): a pragmatic randomised trial. Lancet Glob Health. 2025 Apr;13(4):e707-e715. doi: 10.1016/S2214-109X(24)00527-8.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available to other investigators on reasonable request after publication of the primary results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Manager and Peer Support Group in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
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 2 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 18 Jan 2024. 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 Uganda. 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?
Secondary Prophylaxis Adherence (time frame: 12 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 NCT05502042, which also lists 1 linked publication.
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 18 Jan 2024.