Palliative CareSPARKNCT04862169
Strengthening Palliative Care in Primary Health Care Through Knowledge Enhancement
A study testing educational intervention (SPARK) and electronic version of the modules in people with Palliative Care and Nurse, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The implementation of palliative care has been started in Indonesia since 2007. This was declared by Ministry of health regulation (SK Menkes no 812/Menkes/SK/2007). However, there has been a slow development in palliative care compared to other Asian countries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Nurse, Community Health Services
- What is being tested?
- educational intervention (SPARK) and electronic version of the modules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Jul 2021to 30 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Nurses who currently work in Primary Health Center (PHC) in Yogyakarta, Indonesia, at least for one year;
- Able to access the Internet; and
- Willing to be part of the study.
Who cannot join
- Nurses working in PHC Yogyakarta but unable to provide consent due to some limitations (on leave, do not have enough time, do not have Internet access, temporary leaving job due to study commitment, etc.)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Primary Health Center
Yogyakarta, Special Region of Yogyakarta, 55581
About this study
Official title: Strengthening Palliative Care in Primary Health Care Through Knowledge Enhancement (SPARK) for Nurses in Yogyakarta: A Randomized Control Trial
The implementation of palliative care has been started in Indonesia since 2007. This was declared by Ministry of health regulation (SK Menkes no 812/Menkes/SK/2007). However, there has been a slow development in palliative care compared to other Asian countries. One of the reasons is the lack of knowledge and skills among health care professionals in Indonesia.
Primary Heath Center (PHC) is at the frontline in the health care system in Indonesia to provide care for patients. Its function is especially important in the Universal Health Coverage era. Studies have shown that PHC's nurses' knowledge on palliative care is still limited since the integration of palliative care into the nursing curriculum just started 2-3 years ago. Also, this curriculum integration is still limited in some Universities. Continuing nursing education (CNE) is one of the ways to enhance nurses' knowledge and skills. CNE for palliative care in Indonesian training programs has not been structurally established yet. It is fragmented in its application into some areas and has not been applied for the majority of areas in Indonesia.
Investigators aim to develop a palliative care training for PHC nurses using an online format. It will be done in several steps. Firstly, investigators are starting by conducting a review to collect information on what topics are suitable for PHC nurses. Secondly, investigators are developing modules and other educational tools (a virtual education package). Thirdly, those educational packages will be then evaluated by experts. Next, the education package will be integrated into eLOK (e-learning: open for knowledge sharing) at Universitas Gadjah Mada. After that, training for PHC nurses in Yogyakarta using eLOK will be conducted under the acronym: SPARK or Strengthening PAlliative caRe in the community by enhancing nurses' Knowledge (Sinau PAliatif Rame-rame karo eLOK). The effectiveness of SPARK will be measured with a Randomized Control Trial. Investigators will also collect more information on the feasibility of this program using qualitative data collection since investigators expect to refine this program to be applied in a larger area in Indonesia.
Read the detailed description
Palliative care defines as an approach that improved the quality of life of patients and their family caregivers who are facing problems associated with life threatening (WHO, 2010). The definition is referring to any life-threatening illness such as cancer, dementia, heart failure, and so on. The number of people who needs palliative care is increasing significantly with the increasing number of older people and other degenerative diseases. In fact, more than 75%% people who died from serious health disease were in the developing countries (Spruyt, 2018; WHO, 2010).
In Indonesia, palliative care implementation has just started in 2007 under the ministry of health regulation: SK Menteri Kesehatan No 812/Menkes/SK/VII/2007 (Indonesia, 2007). According to this regulation, palliative care is recommended to be implemented in 5 provinces in Indonesia: Jakarta, Surabaya, Yogyakarta, Makasar dan Bali. It should be applied in all health care settings namely: hospital, primary care, and long term institution. However, the practical implementation in Indonesia has been slowly improved.
The first challenge is due to the insufficiently knowledge of palliative care of health care professionals. In Indonesia, palliative care has started in 2007, but it has just been integrated recently into health care curriculum. Another challenge is that palliative care team usually is formed in hospital based. Meanwhile, most patients who need palliative care are based at home. In the low middle income countries, like Indonesia, community plays an important role in palliative care. Therefore, health care professionals in the Primary Health Centre (PHC) need to be prepared for basic palliative care concept (Putranto, Mudjaddid, Shatri, Adli, \& Martina, 2017).
In comparison to other countries in Asian regions, palliative care Indonesia is still slowly developed since Indonesia physician specialist in palliative care has not existed and the scarcity in the drugs regulation (Yamaguchi et al., 2014). Based on the worldwide report in 2015 by the Economist Intelligence Unit (EIU), amongst 80 countries, Indonesia ranked 53rd for palliative care implementation based several indicators: national policies, integration into health care services, hospice services and community engagement (Unit., 2015). Education and training for palliative care for Indonesian health care professional is lacking. Therefore, this should be conducted to accelerate the implementation of palliative care in Indonesia.
The investigators conducted previous study for palliative care implementation in PHC in Yogyakarta from 12 PHCs around Sleman, Kota Yogyakarta and Bantul. It showed that most nurses had not had enough information about palliative care. The concept of palliative care are mixed with other concept such as wound care, homecare and so forth (Unpublished, 2014). Although in Yogyakarta region, palliative care training for nurses and physicians have been performed regularly. However, these trainings were mostly included managerial staff and not the staff who are working directly with the patient. There is a limitation on transferring knowledge from those who attended trainings to those who directly contact with patients.
Conducting a training in a conventional way (face-to-face training) faces some challenges. Although it has plenty advantages as participants and trainee can spend some time to study, but the number of participants is limited due to time and budget. Also during this covid-19 pandemic situation, a conventional education session is hardly possible.
Knowing how important palliative care education for all health care professionals who work in the community, continuing nursing education is essential. In relation to the physical distancing regulation, an online learning can be the most possible solution in order to address this need. In this randomised control trial study, investigators attempt to test the effectiveness of an online learning program for palliative care for PHC nurses in Yogyakarta.
- Conditions
- Palliative Care, Nurse, Community Health Services
- Being tested
- educational intervention (SPARK), electronic version of the modules
- Keywords
- Palliative care, Nurses, Indonesia, Primary Health Center, SPARK Indonesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational intervention (SPARK)Other
There are 3 modules with 11 chapters. These topics were considered as the most relevant topics for implementation of palliative care for PHC nurses. Also, topics were selected based on our previous literature review of the previous study on the content of PHC nurses training program.
The first module is the introduction. This consists of three chapters: introduction, support system and effective communication. Total reading time is estimated to be one hour. The second module is about the nursing approach in palliative care. It is estimated to be completed in around 2 hours and 15 minutes. The last module is about end of life care.
The participants are expected to access this module before the scheduled synchronous mode. Modules will be provided in the electronic version, so that participants are able to download and read them on their own devices. We are also providing video as trigger for case study discussion
electronic version of the modulesOther
electronic version of the modules
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | In the control group, they will only receive electronic version of the modules. They are able to access the module on their own devices.
The observation arm will receive the link of eLOK at the end of data collection and follow-ups (week 14). With this link, then they are able to access modules, videos and case studies provide in SPARK. Receives: Other: electronic version of the modules |
| Intervention group | Experimental | The intervention on this RCT is an educational training program: SPARK (Strengthening PAlliative caRe in the community by enhancing nurses' Knowledge). This is an educational intervention using an online method with learning method system (LMS) eLOK hosted by Universitas Gadjah Mada Yogyakarta (Affiliation of authors' team). The intervention includes online discussions and access to eLOK for study materials (modules and videos) and some synchronous meetings. Receives: Other: educational intervention (SPARK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHC nurse' knowledge
Primary outcome of the current study is to measure the changes of the level of knowledge of PHC nurses. Investigators are using Palliative Care Quiz for Nursing Indonesian version (PCQN-i) from baseline to after intervention and to 4 and 8 weeks post intervention. This instrument (N=20 items) measures nurses' knowledge on palliative care which consists of 3 domains: philosophy and principles (4 items); pain and symptom management (13 items); and psychosocial and spiritual care (3 items). Items are responded to by 'true', 'false' and 'don't know' and each correct answer will score 1. The higher score will indicate the greater palliative care knowledge.
Measured: Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)
Secondary outcomes (2)
PHC nurse's difficulty in palliative care
Secondary aims are to measure the changes of perception of PHC nurses in the implementation of palliative care in the community using Palliative Care Difficulty Scale (PCDC). It is a validated tool to quantify the levels of difficulty when health professionals provide palliative care. This instrument (N=18 items) includes five subscales: expert support, alleviating symptoms, community coordination, communication in multidisciplinary teams and communication with patients and families. Each subscale has three items graded on a 5 point Likert-type scale from 1 = never to 5 = very much. A higher value means more perceived difficulties, with a possible score range from 1 to 5.
Measured: Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)
PHC nurse's practice report
Another secondary aim is to measure the changes of reporting implementation of palliative care in the community using the Palliative Care Self-Reported Practice Scale. It is a validated tool to quantify the levels of adherence to recommended practices in palliative care (N=15 items). This scale is comprised of six sub scales graded on a 5 point Likert-type scale from never to very much. A higher value means closer adherence to recommended practices in palliative care, with possible score range from 1 to 5.
Measured: Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start25 Jul 2021
- Primary completion1 Nov 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention on this RCT is SPARK (Sinau PAlliative Rame-rame bareng eLOK) OR Strengthening PAlliative caRe in the community by enhancing nurses' Knowledge). This is an educational intervention using an online method with learning method system (LMS) eLOK hosted by Universitas Gadjah Mada Yogyakarta (Affiliation of authors' team). The intervention includes online discussions and access to eLOK for study materials (modules and videos).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Sinta Kristanti, Gadjah Mada University
- Investigators
- Martina Sinta Kristanti, PhD, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862169
- Sponsor's protocol ID
- SPARK project 2021
- Acronym
- SPARK
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2021
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon the request to principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Palliative Care in Primary Health Care Through Knowledge Enhancement (SPARK) for Nurses in Yogyakarta: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04862169
- Acronym / sponsor ID
- SPARK / SPARK project 2021
- Conditions
- Palliative Care, Nurse, Community Health Services
- Keywords
- Palliative care, Nurses, Indonesia, Primary Health Center, SPARK Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 27 Apr 2021 (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 implementation of palliative care has been started in Indonesia since 2007. This was declared by Ministry of health regulation (SK Menkes no 812/Menkes/SK/2007). However, there has been a slow development in palliative care compared to other Asian countries. One of the reasons is the lack of knowledge and skills among health care professionals in Indonesia.
Primary Heath Center (PHC) is at the frontline in the health care system in Indonesia to provide care for patients. Its function is especially important in the Universal Health Coverage era. Studies have shown that PHC's nurses' knowledge on palliative care is still limited since the integration of palliative care into the nursing curriculum just started 2-3 years ago. Also, this curriculum integration is still limited in some Universities. Continuing nursing education (CNE) is one of the ways to enhance nurses' knowledge and skills. CNE for palliative care in Indonesian training programs has not been structurally established yet. It is fragmented in its application into some areas and has not been applied for the majority of areas in Indonesia.
Investigators aim to develop a palliative care training for PHC nurses using an online format. It will be done in several steps. Firstly, investigators are starting by conducting a review to collect information on what topics are suitable for PHC nurses. Secondly, investigators are developing modules and other educational tools (a virtual education package). Thirdly, those educational packages will be then evaluated by experts. Next, the education package will be integrated into eLOK (e-learning: open for knowledge sharing) at Universitas Gadjah Mada. After that, training for PHC nurses in Yogyakarta using eLOK will be conducted under the acronym: SPARK or Strengthening PAlliative caRe in the community by enhancing nurses' Knowledge (Sinau PAliatif Rame-rame karo eLOK). The effectiveness of SPARK will be measured with a Randomized Control Trial. Investigators will also collect more information on the feasibility of this program using qualitative data collection since investigators expect to refine this program to be applied in a larger area in Indonesia.
Detailed description
Palliative care defines as an approach that improved the quality of life of patients and their family caregivers who are facing problems associated with life threatening (WHO, 2010). The definition is referring to any life-threatening illness such as cancer, dementia, heart failure, and so on. The number of people who needs palliative care is increasing significantly with the increasing number of older people and other degenerative diseases. In fact, more than 75%% people who died from serious health disease were in the developing countries (Spruyt, 2018; WHO, 2010).
In Indonesia, palliative care implementation has just started in 2007 under the ministry of health regulation: SK Menteri Kesehatan No 812/Menkes/SK/VII/2007 (Indonesia, 2007). According to this regulation, palliative care is recommended to be implemented in 5 provinces in Indonesia: Jakarta, Surabaya, Yogyakarta, Makasar dan Bali. It should be applied in all health care settings namely: hospital, primary care, and long term institution. However, the practical implementation in Indonesia has been slowly improved.
The first challenge is due to the insufficiently knowledge of palliative care of health care professionals. In Indonesia, palliative care has started in 2007, but it has just been integrated recently into health care curriculum. Another challenge is that palliative care team usually is formed in hospital based. Meanwhile, most patients who need palliative care are based at home. In the low middle income countries, like Indonesia, community plays an important role in palliative care. Therefore, health care professionals in the Primary Health Centre (PHC) need to be prepared for basic palliative care concept (Putranto, Mudjaddid, Shatri, Adli, \& Martina, 2017).
In comparison to other countries in Asian regions, palliative care Indonesia is still slowly developed since Indonesia physician specialist in palliative care has not existed and the scarcity in the drugs regulation (Yamaguchi et al., 2014). Based on the worldwide report in 2015 by the Economist Intelligence Unit (EIU), amongst 80 countries, Indonesia ranked 53rd for palliative care implementation based several indicators: national policies, integration into health care services, hospice services and community engagement (Unit., 2015). Education and training for palliative care for Indonesian health care professional is lacking. Therefore, this should be conducted to accelerate the implementation of palliative care in Indonesia.
The investigators conducted previous study for palliative care implementation in PHC in Yogyakarta from 12 PHCs around Sleman, Kota Yogyakarta and Bantul. It showed that most nurses had not had enough information about palliative care. The concept of palliative care are mixed with other concept such as wound care, homecare and so forth (Unpublished, 2014). Although in Yogyakarta region, palliative care training for nurses and physicians have been performed regularly. However, these trainings were mostly included managerial staff and not the staff who are working directly with the patient. There is a limitation on transferring knowledge from those who attended trainings to those who directly contact with patients.
Conducting a training in a conventional way (face-to-face training) faces some challenges. Although it has plenty advantages as participants and trainee can spend some time to study, but the number of participants is limited due to time and budget. Also during this covid-19 pandemic situation, a conventional education session is hardly possible.
Knowing how important palliative care education for all health care professionals who work in the community, continuing nursing education is essential. In relation to the physical distancing regulation, an online learning can be the most possible solution in order to address this need. In this randomised control trial study, investigators attempt to test the effectiveness of an online learning program for palliative care for PHC nurses in Yogyakarta.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The intervention on this RCT is SPARK (Sinau PAlliative Rame-rame bareng eLOK) OR Strengthening PAlliative caRe in the community by enhancing nurses' Knowledge). This is an educational intervention using an online method with learning method system (LMS) eLOK hosted by Universitas Gadjah Mada Yogyakarta (Affiliation of authors' team). The intervention includes online discussions and access to eLOK for study materials (modules and videos).
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: electronic version of the modulesIn the control group, they will only receive electronic version of the modules. They are able to access the module on their own devices. The observation arm will receive the link of eLOK at the end of data collection and follow-ups (week 14). With this link, then they are able to access modules, videos and case studies provide in SPARK. |
| Intervention group | Experimental | Other: educational intervention (SPARK)The intervention on this RCT is an educational training program: SPARK (Strengthening PAlliative caRe in the community by enhancing nurses' Knowledge). This is an educational intervention using an online method with learning method system (LMS) eLOK hosted by Universitas Gadjah Mada Yogyakarta (Affiliation of authors' team). The intervention includes online discussions and access to eLOK for study materials (modules and videos) and some synchronous meetings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Nurses who currently work in Primary Health Center (PHC) in Yogyakarta, Indonesia, at least for one year;
- Able to access the Internet; and
- Willing to be part of the study.
Key exclusion criteria (1 listed)
- Nurses working in PHC Yogyakarta but unable to provide consent due to some limitations (on leave, do not have enough time, do not have Internet access, temporary leaving job due to study commitment, etc.)
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 |
|---|---|---|
| educational intervention (SPARK)There are 3 modules with 11 chapters. These topics were considered as the most relevant topics for implementation of palliative care for PHC nurses. Also, topics were selected based on our previous literature review of the previous study on the content of PHC nurses training program. The first module is the introduction. This consists of three chapters: introduction, support system and effective communication. Total reading time is estimated to be one hour. The second module is about the nursing approach in palliative care. It is estimated to be completed in around 2 hours and 15 minutes. The last module is about end of life care. The participants are expected to access this module before the scheduled synchronous mode. Modules will be provided in the electronic version, so that participants are able to download and read them on their own devices. We are also providing video as trigger for case study discussion | Other | Intervention group |
| electronic version of the moduleselectronic version of the modules | Other | Control group |
Primary outcome
PHC nurse' knowledge
Time frame: Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)
Primary outcome of the current study is to measure the changes of the level of knowledge of PHC nurses. Investigators are using Palliative Care Quiz for Nursing Indonesian version (PCQN-i) from baseline to after intervention and to 4 and 8 weeks post intervention. This instrument (N=20 items) measures nurses' knowledge on palliative care which consists of 3 domains: philosophy and principles (4 items); pain and symptom management (13 items); and psychosocial and spiritual care (3 items). Items are responded to by 'true', 'false' and 'don't know' and each correct answer will score 1. The higher score will indicate the greater palliative care knowledge.
2 secondary outcomes
PHC nurse's difficulty in palliative care
Time frame: Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)
PHC nurse's practice report
Time frame: Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)
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 11 Jul 2024.
- Individual participant dataSharing planned: Yes. Data will be shared upon the request to principle investigator
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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.
Martina Sinta Kristanti, PhD principal investigator
Gadjah Mada 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 educational intervention (SPARK) and electronic version of the modules in people with Palliative Care and Nurse, run by Gadjah Mada University at 1 site in Indonesia.
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 3 inclusion and 1 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 11 Jul 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
PHC nurse' knowledge (time frame: Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)). 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 11 Jul 2024.