NCT04862169

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

April 22, 2021

Last Update Submit

July 10, 2024

Conditions

Keywords

Palliative careNursesIndonesiaPrimary Health CenterSPARK Indonesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)

  • PHC nurse's practice report

    Week 0 (baseline), Week 5 (after intervention), Week 10 (follow up), Week 14 (follow up)

Study Arms (2)

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.

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.

Other: educational intervention (SPARK)

Interventions

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

Intervention group

electronic version of the modules

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Center

Yogyakarta, Special Region of Yogyakarta, 55581, Indonesia

Location

Study Officials

  • Martina Sinta Kristanti, PhD

    Gadjah Mada University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Allocation concealment will use sealed envelopes. Randomization will be done by concealing a piece of paper that has the phrase "Intervention (SPARK)" or "Control (MODULE only)" which will be placed inside a thick envelope. The outside of the envelopes will be labelled with the sequence number. After a participant has been enrolled into the study and consented, the next sequence numbered envelope on the stack will be opened to determine the study group that the subject will enter.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, Assistant Professor

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 27, 2021

Study Start

July 25, 2021

Primary Completion

November 1, 2021

Study Completion

December 30, 2021

Last Updated

July 11, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Data will be shared upon the request to principle investigator

Shared Documents
STUDY PROTOCOL
Time Frame
in 2022

Locations