ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1837 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-08-30

Brief Summary

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The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are:

1. To test and estimate the effect of the intervention in people with MLTCs attending

PHCs on:

i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care
2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance.
3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention.

The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

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Detailed Description

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Control facilities Participants in control facilities will continue to receive usual care. Primary health care of long-term conditions is delivered free-at-point-of-care in public sector primary care facilities which includes the management of HIV, NCDs and mental health problems, according to South Africa's Ideal Clinic and Integrated Clinical Services Management model. This care model, which has combined the long-term care of HIV together with NCDs within each facility, has greatly enabled the feasibility of further interventions specifically addressing MLTCs and includes the Adult Primary Care (APC) or PACK clinical guidance. Patients attending these chronic services usually attend the same clinic regularly, 3 to 6-monthly for periodic monitoring of their chronic conditions. Chronic medication is collected monthly either at the facility (through fast-track queues), or through decentralised chronic medication dispensing systems which provide for collection from a range of sites including community venues (e.g. halls), wellness or adherence clubs, trailers, retail pharmacies (in KZN) or e-Lockers.

Intervention clinics

Participants in intervention clinics will continue with usual care as described for control clinics but in addition will receive the ENHANCE health systems intervention comprising tools and implementation strategies that have been co-developed with stakeholders through an iterative process, drawing on:

i. Evidence on the commonest MLTC combinations ii. Scoping reviews conducted on effectiveness of MLTCS interventions and systems barriers and enablers of person-centred care for MLTCs in LMICs iii. Provincial and district learning collaborative workshops with stakeholders from KZN and Western Cape.

iv. Clinical working groups with clinicians and health workers, a Guidance Oversight Board v. Input from our ENHANCE advocacy academy of 16 people living with MLTCs in the Western Cape and KZN

The intervention targets screening and early identification of other chronic conditions; improving follow-up and support for people with a new diagnosis, at risk of treatment failure (e.g. poorly controlled HIV or diabetes), and strengthen bi-directional referral pathways between the facility and community. Tools and implementation strategies will be layered into existing architecture of the chronic care system and support provision of more person-centred and empowering care across the treatment cascade.

Tools to support the implementation of the health systems intervention comprise:

* An integrated clinical decision support tool for care of MLTCs drawing on PACK/ APC.
* A range of patient-focussed materials to support condition, treatment, and systems (care-seeking) literacy (e.g., medication list, posters, scripts for health education talks)
* A personal health diary (paper-based)

Implementation strategies include:

* 1 facility team session to introduce the ENHANCE study to the whole team
* 3 clinical sessions for nurses and doctors
* 2 sessions for community health workers and health promoters
* Maintenance sessions to keep the ENHANCE intervention going for at least 12 months.

Conditions

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HIV Infections Hypertension Diabetes Mellitus Asthma Depression Myocardial Infarction Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a type 2 hybrid trial, testing the effect of the intervention in improving clinical outcomes, and also testing and observing the effects of the intervention on implementation processes and outcomes using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The trial will be a cluster randomised parallel arm trial with embedded process evaluation.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

1. Treatment literacy in chronic condition waiting rooms/pick-up points (posters, health promotion talks)
2. 1-2 longer consultations with ENHANCE guide trained clinician
3. Treatment literacy event - a contact between a CHW and a person with MLTC in their home (hopefully with carer), at 2 weeks and 4 weeks, using Health Diary
4. Referrals to additional adherence counselling if necessary

Group Type OTHER

ENHANCE intervention (health systems)

Intervention Type OTHER

The intervention tools include a consolidated clinical decision support tool, health education posters, waiting room talks, medication list for treatment literacy and a patient health diary. Training session are delivered at all intervention sites and include 1 facility team session to introduce the ENHANCE study to the whole team; 3 clinical sessions for nurses and doctors; 2 sessions for community health workers and health promoters; Maintenance sessions to keep the ENHANCE intervention going for at least 12 months

Control

Usual care at primary health care clinic, which includes consultation with a clinician using the PACK/APC guide. No additional support is usually provided for care of MLTCs.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ENHANCE intervention (health systems)

The intervention tools include a consolidated clinical decision support tool, health education posters, waiting room talks, medication list for treatment literacy and a patient health diary. Training session are delivered at all intervention sites and include 1 facility team session to introduce the ENHANCE study to the whole team; 3 clinical sessions for nurses and doctors; 2 sessions for community health workers and health promoters; Maintenance sessions to keep the ENHANCE intervention going for at least 12 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged 40 years and older
* At least two of the following conditions:

i. HIV (Self-reported current treatment). ii. hypertension (Self-reported current treatment. iii. diabetes (Self-reported current treatment). iv. asthma, (Self-reported current treatment). vi. depression (Self-reported current treatment). vii. previous myocardial infarction (self-reported). viii. previous stroke (self-reported history).

Exclusion Criteria

* Participants planning to relocate from either uMgungundlovu KwaZulu Natal and Cape Metro in Western Cape or changing their facilities during the period of the study.
* Participants who are unable to give informed consent due to loss of capacity.
* Participants self-reporting pregnancy
* Participants who cannot communicate in English, isiXhosa, isiZulu, or Afrikaans.
* Participants who are not willing to receive care for chronic conditions in their homes.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Inge Petersen

Director, Centre for Rural Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Schneider, PhD

Role: STUDY_CHAIR

University of the Western Cape

Locations

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Eastwood Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Esigodini Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Gcumisa Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Gomane Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Howick Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Impilwenhle Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Injabulo Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Mafatini Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Mphophomeni Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Ndaleni Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Northdale Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Pata Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Richmond Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status

Songonzima Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Site Status