Efficacy of health coaching intervention to improve self-care management of hypertension among older people in Indonesia: A randomized controlled study

Last registered on April 13, 2023

Pre-Trial

Trial Information

General Information

Title
Efficacy of health coaching intervention to improve self-care management of hypertension among older people in Indonesia: A randomized controlled study
RCT ID
AEARCTR-0011209
Initial registration date
April 08, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
April 13, 2023, 4:05 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
Hasanuddin University

Other Primary Investigator(s)

PI Affiliation
University of Michigan

Additional Trial Information

Status
In development
Start date
2023-08-01
End date
2024-03-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Background: The worldwide burden of Hypertension (HTN) is increasing due to an aging population predicted to affect one-third of the world's population by 2025. In Indonesia, the highest percentage of HTN was among the 65-74 age group (63.2%). Furthermore, uncontrolled HTN led to a primary risk factor for stroke, heart disease, and kidney failure. Among older people, the additional increased risk was vascular dementia and Alzheimer's Disease . Our recent scoping review found that there was variability among people in self-care management, indicating that each hypertensive subject had a specific and personalized challenge in practicing HTN self-care. Health coaching may be a method to solve this gap.
Aim: To determine the efficacy and sustainable impact of an Indonesian adaptation of an 8-week nurse health coaching intervention on self-care management and self-efficacy in older people with HTN.
Methods: This is a randomized 2X3 repeated measure experimental design. We plan to recruit 140 older people with HTN living in Makassar, South Sulawesi, Indonesia, aged 60 years old and above, having been diagnosed with hypertension by a medical doctor, taking antihypertensive medication, and medically stable. Data measurement will be taken thrice: baseline, 1 week after health coaching intervention and 3 months follow-up after no intervention. During 8th week coaching intervention, researcher and participants will identify the priority goals and small-step plans, discuss barriers and facilitators for achieving the action steps, improve self-care skills and provide supportive coaching to achieving participants goals.

Discussion: Managing HTN self-care in Indonesia and other South East Asian countries might differ from the Western area due to different cultures, lifestyles, and geographical backgrounds. This study will be the first study to include motivational interviewing and cognitive behavioral approach and to test the sustainability of the health coaching program's impact after three months of no intervention with Indonesian backgrounds.
External Link(s)

Registration Citation

Citation
Irwan, Andi Masyitha and Kathleen Potempa. 2023. "Efficacy of health coaching intervention to improve self-care management of hypertension among older people in Indonesia: A randomized controlled study." AEA RCT Registry. April 13. https://doi.org/10.1257/rct.11209-1.0
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Experimental Details

Interventions

Intervention(s)
At the first week of intervention, researcher and participants will go over the result of baseline measurement. During the second to fifth week, researcher and participants will identify the priority goals and small-step plans, discuss barriers and facilitators for achieving the action steps. The researcher will also notice and evokes change talk providing supportive statements as the participant describes barriers, facilitators, and intent to take action steps toward their goals. The researcher will engage the participant, with their permission and MI methods, in teaching specific techniques to improve self-care skills and provide supportive coaching as they change behavior toward achieving their goals.
On the sixth week of the pilot study, the researcher will remind the participant that the survey will end in two weeks. It is expected that the participants of this pilot study will be able to disengage from their participation easily, and they will be assisted by providing them with anticipatory guidance'' of the end of the study program. The researcher will assess the participant's progress and readiness to disengage from the study. The researcher will prepare the participant for dis-engagement by co-creating with them the loose end'' they want to address by the end of the final session. Sessions seven and eight will focus on these issues and also go over the procedure for completing the post-study measures. When the study is accomplished, we will visit the participants at their houses once again to explain the result of the study.
Intervention Start Date
2023-08-13
Intervention End Date
2024-03-01

Primary Outcomes

Primary Outcomes (end points)
Hypertension self-care
Primary Outcomes (explanation)
Hypertension Self-Care Profile (HBP SCP). The HBP SCP is a questionnaire consisting of 60 items grouped into three sections–Motivation, Behaviour, and Self-efficacy; each section has 20 items that can be used together or independently. The HBP SCP was developed based on Orem's self-care model and Motivational Interviewing. It used the Likert Scale with four scales, namely very confident (4), confident (3), less confident (2), and not confident (1), with the highest score of 80 and the lowest 20.

Secondary Outcomes

Secondary Outcomes (end points)
blood pressure, anthropometric measurement,cholesterol and glucose level and salt concentration
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
This is a randomized 2X3 repeated measure experimental design. A randomized control trial is chosen as the study design because it delivers the highest level of evidence due to its potential to limit all sorts of bias.
Experimental Design Details
Randomization Method
randomization done in office by a computer
Randomization Unit
individual
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
1 public health centre
Sample size: planned number of observations
500 older people
Sample size (or number of clusters) by treatment arms
We plan to recruit 140 older people with HTN living in Makassar, South Sulawesi, Indonesia, as the participants based on the Slovin formula for 5% significance error and 95% power to detect effect size. Therefore, each group will have 70 members.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
Health Sciences and Behavioral Sciences Institutional Review Board
IRB Approval Date
2023-03-21
IRB Approval Number
HUM00214318
IRB Name
Hasanuddin University Ethics Committee of Medical Research
IRB Approval Date
2022-09-20
IRB Approval Number
UH22080448

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials