Effects of Health-social Partnership Programme

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

COMPLETED

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-03-31

Brief Summary

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This paper aims to describe the research protocol that will be used to determine the effectiveness of a health-social partnership intervention programme among community-dwelling older adults

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Detailed Description

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A staff of community center in service area who will not take part in the study will be involved in drawing a list of potential participants from the accessible population. Simple random sampling will be adopted to recruit participants. Those who meet the inclusion and exclusion criteria and agree to participate in the research study will be assigned to intervention group or customary care group according to the result of randomization.

Sample size calculation was based on power analysis. Power analysis adopts a hypothesis-testing method to determine sample size according to several parameters which include pre-specified significance level, desired power level and expected effect size. Assuming a two-tailed alpha of 0.05, a probability of 0.2 for beta error (80% power), and an effect size of 0.28 after calculating with respect to the same primary outcome measure (self-efficacy) from results of two previous researches which provide home visit and telephone follow up to older adults, 200 subjects per group are required. With reference to the 10% to 15% attrition reported in previous community-dwelling elderly program, assume there is a 20% drop out rate in this study, the total sample size needed is 240 subjects per group i.e. a total of 480 subjects.

In order to assure that the numbers of both groups are equal, a block randomization method will be used. Before randomization, a project team member who will not be involved in the subject recruitment and data collection will prepare a block randomization list with 240 sets of numbers which is either 0 (customary care group) or 1 (intervention group) by using a computer software Research Randomizer (http://www.randomizer.org/). These 240 sets of numbers will be printed out separately and sealed in each envelope. Another project team member, who successfully recruits a subject, will unfold an envelope by sequence after the enrolled participants finished all the baseline assessment and ready for interventions. The number written in the envelope will represent the group of that particular subject.

The group assignments will keep blinded to participants during the whole study period. However, the nurse case manager who will provide care to the participants will know the group allocation. Therefore, this study is a single-blinded design. In order to minimize bias, the nurse case manager will not participate in the data collection procedure.

Descriptive analysis will be calculated using mean and standard deviation for continuous variables, percentage and frequency for categorical variables, and median and quartile range when the continuous variables are not normally distributed. Independent t-tests, Mann-Whitney U test, chi-square test or Fisher's exact test will be used to compare any differences in socio-demographic data or outcome variables between groups. Significant results are indicated if p-value of all statistical analysis is less than 0.05 for two-tailed test. To determine the differences or changes between study group and control group (between group effects), within group effects (time), and the interaction effects (group x time), two way repeated measures Analysis of variances (ANOVA) or co-variances (ANCOVA) will be applied when assumptions for parametric test are fulfilled. When the data cannot fulfill the assumptions of parametric test, Mann-Whitney U test will be applied to compare the differences between groups at each time interval while Friedman test will be used to determine the time effects within each group.

The missing data in the present study will be handled by intention-to-treat (ITT) analysis. Sensitivity analysis will be adopted to compare the results using different missing data handling approach according to the Crochrane Handbook for Systematic Reviews of Interventions. Data will be computed and analyzed with the assistant of the Statistical package of Social Sciences (SPSS) version 21 software (SPSS Inc., Chicago).

All questionnaires for measuring the outcome variables in this study have been demonstrated good validity and reliability. Nurse case managers and social workers will be trained by the research team members in order to provide consistent interventions from various professionals in the health-social care team and ensure the quality of the program. The nurse case managers will be employed with a criterion of experienced community nursing background. The process of home visits and telephone conversation will be recorded for review and evaluation. The research team members and health-social care team members will have meeting regularly to discuss the cases so as to ensure the practice is aligning with the protocols. This randomized controlled study will also stringently follow the Consolidated Standards of Reporting Trials (CONSORT) statement.

Conditions

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Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

Interventions include providing comprehensive assessment from Omaha system, giving information regarding the self-care management, assisting and coordinating self-regulating skills and abilities, and providing social support from health-social care team to community-dwelling older adults for three months

Group Type EXPERIMENTAL

Intervention group

Intervention Type BEHAVIORAL

A structured assessment is conducted using the Omaha system. Problems will be identified in the four domains which include environment, psychosocial, physiological and health-related behavior. According to the identified problems, the nurse case manager and older adults will set contract goals and formulate an individual care plan. The nurse case manager will provide information on the basic knowledge of participants' own chronic illnesses; recognition, measurement and management of the early signs and symptoms of a deterioration or exacerbation of diseases; and the importance of health-promoting and self-care activities. A booklet will be given to them for easy reference and act as a reminder to consolidate the knowledge in case the important concepts are forgotten.

customary care group

Customary care includes receiving community services from the community center in the district, providing monthly social call by a reserch assistant for three months

Group Type PLACEBO_COMPARATOR

Intervention group

Intervention Type BEHAVIORAL

A structured assessment is conducted using the Omaha system. Problems will be identified in the four domains which include environment, psychosocial, physiological and health-related behavior. According to the identified problems, the nurse case manager and older adults will set contract goals and formulate an individual care plan. The nurse case manager will provide information on the basic knowledge of participants' own chronic illnesses; recognition, measurement and management of the early signs and symptoms of a deterioration or exacerbation of diseases; and the importance of health-promoting and self-care activities. A booklet will be given to them for easy reference and act as a reminder to consolidate the knowledge in case the important concepts are forgotten.

Interventions

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Intervention group

A structured assessment is conducted using the Omaha system. Problems will be identified in the four domains which include environment, psychosocial, physiological and health-related behavior. According to the identified problems, the nurse case manager and older adults will set contract goals and formulate an individual care plan. The nurse case manager will provide information on the basic knowledge of participants' own chronic illnesses; recognition, measurement and management of the early signs and symptoms of a deterioration or exacerbation of diseases; and the importance of health-promoting and self-care activities. A booklet will be given to them for easy reference and act as a reminder to consolidate the knowledge in case the important concepts are forgotten.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* People aged 60 or above
* Living within the service area
* Cognitively competent with Chinese version Mini-Mental Status Examination (C-MMSE) with score ≥ 20 (Wong, et al., 2011)

Exclusion Criteria

* Not communicable
* Bed bound
* Not reached by phone
* With psychiatric problems
* Already engaged in structured health or social programs
* Will not stay in Hong Kong for the current two months

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes