Clinical trial NCT02286375: Effects of Health-social Partnership Programme
Official title: Health-social Partnership Intervention Programme for Community-dwelling Older Adults: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: health-social partnership
self-efficacy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 460
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome will measure the community living older adults the change from baseline in self-efficacy belief in self-care management at home at 3-months and 6-months
timeFrame: pre-intervention, 3-month, 6-month
Secondary outcomes:
measure: the change of medication adherence to chronic medications from baseline to 3-months and 6-months for community-living older adults
timeFrame: pre-intervention, 3-month, 6-month
measure: the change from baseline in physical activity level of community living older adults at 3-months and 6-months
timeFrame: pre-intervention, 3-month, 6-month
measure: the change from baseline in activity of daily living level at 3-months and 6-months
timeFrame: pre-intervention, 3-month, 6-month
measure: the change from baseline in Instrumental activity of daily living level at 3-months and 6-months
timeFrame: pre-intervention, 3-month, 6-month
measure: nutritional status of community-living older adults from pre-intervention to post intervention at 3-months and 6-months
timeFrame: pre-intervention, 3-month, 6-month
measure: the chnage of perception of quality of life from baseline to at 3-months and 6-months post-intervention
timeFrame: pre-intervention, 3-month, 6-month
measure: the change of depression level of community living older adults from baseline to at 3-months and 6-months post-intervention
timeFrame: pre-intervention, 3-month, 6-month
measure: change from baseline in life satisfaction of community living older adults at 3-months and 6-months
timeFrame: pre-intervention, 3-month, 6-month
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Salvation army
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arkers Wong, Msc
role: PRINCIPAL_INVESTIGATOR
References:
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