Home » Trials » SLCTR/2019/003


A non randomized clinical trial on effectiveness of a community healthcare package aimed at improving the accessibility of healthcare services for the elderly in Colombo district.

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SLCTR Registration Number

SLCTR/2019/003


Date of Registration

16 Jan 2019

The date of last modification

Feb 11, 2019



Application Summary


Scientific Title of Trial

A non randomized clinical trial on effectiveness of a community healthcare package aimed at improving the accessibility of healthcare services for the elderly in Colombo district.


Public Title of Trial

Effectiveness of a community healthcare package aimed at improving the accessibility of healthcare services for the elderly in Colombo District


Disease or Health Condition(s) Studied

Accessibility to primary healthcare services


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1225-8420


Any other number(s) assigned to the trial and issuing authority

P/119/5/2018 (ERC:Kelaniya)


Trial Details


What is the research question being addressed?

Does a community healthcare intervention package effectively improve the healthcare accessibility among the elderly in Colombo district


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Health services research


Study Phase

Not Applicable


Intervention(s) planned

This is a quasi-experimental study.

One DS division, out of 13 DS divisions in Colombo District will be selected to carry out the intervention and one DS division for the control arm.

Intervention group will be provided with the community health care package. It includes brief geriatric assessment and health education module aiming to improve the knowledge on chronic diseases and health promotion behaviours.

It will be delivered through a team of members comprised of Public health nursing officer, MOH, AMOH Health education officer and Social service officer at healthy life center (HLC). HLC centers are conducted by medical officers, nursing officers and health education officers in health care institutions for people between age 35-65 years to provide health guidance , screening, basic treatment and referral and follow up.Workshop will be conducted for the training of service providers with regard to the modules incorporated in the community healthcare package with the help of experts.

In selected DS division for the intervention, one GN area will be selected randomly and elderly population details will be obtained from GN officer. One household will be selected randomly as the starting point and subsequent houses to the right hand side, when facing the entrance will be selected until the required number of participants are selected.If more than one person fulfill a selection criteria in a same household one person will be selected randomly by allocating a number to each of these persons.

There will be four sessions conducted for the intervention group, in which first three sessions will be held once a week and the fourth session will be conducted three weeks after the last session. Duration of each session will be 3-4 hours.

At the beginning of the intervention a self-reading leaflet on active ageing will be provided to the all participants in intervention group.

Control arm will be provided with usual care.


Inclusion criteria

Male and female elders who are aged 60 years and above. Resident in Colombo district , continuously for six months prior to the survey.


Exclusion criteria

Institutionalized elderly Elderly who exhibit physical and mental incompetence.



Primary outcome(s)

  1. Healthcare service utilisation - following service utilization indicators will be used
    1.1 Percentage of elderly referred for appropriate care after the geriatric assessment out of those who participated in the geriatric assessment module.Elderly identified with ailments will be referred to necessary healthcare centers by the Medical officer who carried out the assessment.
    1.2. Percentage of elderly who participate in at least two sessions of the community health care package out of those who selected to participate.

    [

    6 weeks after the implementation of the intervention

    ]
  2. Health care access will be measured at the end of the intervention by using a questionnaire on availability and acceptability of the services provided through community healthcare package and improvement in health access will be determined by the scores obtained.

    [

    6 weeks after the implementation of the intervention

    ]

Secondary outcome(s)

  1. Health knowledge score- a questionnaire was formulated to assess the health knowledge on disease prevention, health promotion and chronic disease management. Improvement in the health knowledge will be determined by comparison of scores obtained before and after the intervention

    [

    At baseline - at the beginning of the intervention and six weeks after the implementation of the intervention.

    ]

Target number/sample size

90 elders for the intervention group and 90 for the control group


Countries of recruitment

Sri Lanka


Anticipated start date

2019-01-21


Anticipated end date

2019-03-11


Date of first enrollment

2019-01-18


Date of study completion


Recruitment status

Recruiting


Funding source

None (Investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-06-26


Approval number

P/119/05/2018


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address: PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone: +94-11-2961267
Email: erckelaniya@gmail.com


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

H N A Fonseka
Registrar in Community Medicine
Nutrition Division, 5th floor,Public Health Complex, Elvitigala Mawatha, Narahenpita.
0112368320
0718047860
0112368583
fony_14@yahoo.co.in

Contact Person for Public Queries

Aindralal Balasuriya
Consultant Community Physician/Senior Lecturer/ Head,Public Health and Family Medicine
Faculty Of Medicine, General Sir John Kotelawala Defence University, Ratmalana
0112635268
0718427086
0112638660
dr.balasuriya@yahoo.com


Primary study sponsor/organization

H N A Fonseka

Nutrition Division, 5th floor,Public Health Complex, Elvitigala Mawatha, Narahenpita, Sri Lanka
0112368320
0718047860
fony_14@yahoo.co.in

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data that underlie the results will be shared after the de-identification (tables,figures,appendices). This will be immediately following publication (no end date). Data sharing will be with investigators whose proposed use of the data has been approved by an independent review committee/ethical review committee identified for this purpose, to achieve the aims of the approved proposal. Proposals should be directed to fony_14@yahoo.co.in


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results