Individualized counselling for active aging: protocol of a single-blinded, randomized controlled trial among older people (the AGNES intervention study)

The AGNES intervention will recruit participants from the ongoing AGNES cohort study [39], which is an observational study of three age cohorts (75, 80, and 85 years) living independently in the municipality of Jyväskylä, Finland. Inclusion criteria for the RCT study will be age 75 or 80, a baseline score between 52.3 and 90.0 on the University of Alabama at Birmingham Life-Space Assessment (LSA; [35, 40]), and a score of 25 or higher on the cognitive function test (MMSE; [41]). Recruitment has started in October 2017 and will continue until the number of participants reaches 200.

Participants in the AGNES cohort study [39] who have consented to future study requests will be assessed for eligibility for the RCT. Following the cohort study baseline assessments, eligible participants will be offered an opportunity to join the trial. Willing participants will receive a short verbal briefing and written information, including a consent form that they can read at their leisure. Within 2 weeks, the intervention counsellor will call potential participants to confirm their willingness to participate in the study and, if necessary, to provide them with additional information on the study. Once the participant will provided verbal consent, the pre-trial interview will be conducted over the phone. After the interview, the counsellor will open the randomization envelope and inform the participant about the treatment group. The signed written informed consent form will be returned by post or in person.

Data collection will be performed at three time points: pre-trial, mid-trial (at sixth months), and post-trial (at 12 months) by trained research assistants. The pre-trial data will derive from a face-to-face interview in the participants’ homes, a postal questionnaire completed by the participant, 1 week of physical activity surveillance using accelerometers and the phone interview conducted by the counsellor. The mid-trial and post-trial data collections will be conducted using face-to-face interviews in the participants’ homes followed by 1 week of physical activity surveillance with accelerometers (post-trial only). The interviewers have participated in a training course on interviewing techniques suitable for use with older people, study ethics and safety as well as practice sessions. Incoming data will be monitored periodically. Figure 1 shows the data collection timeline in months and participant contacts by group.

After randomization, the intervention (CG) group will participate in a 90-min, face-to-face, individual counselling session on the premises of the University of Jyväskylä. A trained counsellor with previous experience in counselling older adults will deliver all the counselling sessions. The counselling session follows a semi-structured protocol of questions. The main body of the questions initiating discussion topics is the same for all participants. Additional probing questions will be based on the participants’ answers. The main body of questions guiding the counselling session consists of four sections, (a) Introduction and building rapport; b) Current activities and change talk; c) Goal setting, action plans and how to use the supportive materials that we provide (booklet, calendar and newsletter); and d) Wrapping up and closure. During the face-to-face counselling sessions, participants will receive an information booklet on active aging [47] from the counsellor. The Information Booklet is 64 pages long and provides information about activities and behaviors that promote active aging, with self-help exercises and techniques that the participants can use to facilitate their planned changes, and a calendar that they can use to monitor their activities. Participants will be instructed to use the information booklet as support during the one-year intervention.

After the initial face-to-face session, participants will receive four phone counselling sessions, at 1, 3, 6 and 9 months after the face-to-face counselling session. The aim of the sessions is to provide them with additional support, feedback and encouragement. The content of the follow-up phone calls will be a discussion about the participant’s progress towards achieving their goals, sharing in their successes or failures, and further encouragement to continue their efforts towards increasing their activities. The duration of these short counselling contacts is expected to be 20–30 min. In addition, participants will receive four printed newsletters, the first during the first counselling session, and the other three by mail 1 week before the phone sessions at 3, 6, and 9 months. The newsletters will feature the activities that are currently organized for older people in the Jyväskylä area and the success stories of people who are living an active life. A description of the Behavior Change Techniques (BCTs) used in the AGNES intervention [48] is displayed in Table 1.

Two intervention providers will receive the training. They both have postgraduate degrees in health sciences and they will take part in six two-hour sessions to develop the skills needed for autonomy-supportive counselling. The training sessions will be supported by printed material and include a group discussion section and a practice session with feedback. The topics of the six sessions were: a) The self-determination approach in behavior change interventions, b) Motivational interviewing strategies, c) Planning autonomy-supportive sessions tailored to the individual, d) Using autonomy-supportive communication/language, e) Applying the behavior change techniques in an autonomy-supportive way, and f) Profiling practice in hypothetical case studies.

Participants allocated to the control group will receive printed general health information material of the kind used in usual health care services for older people. The envelope with the printed material (brochures, booklets etc.) will be mailed by post to the control group participants during months 1, 3, 6, and 9. The material is divided into four themes. The first theme is “Exercise”, the second “Nutrition”, the third “Cardiovascular diseases”, and the last “Type II diabetes”. We do not expect the control group to exhibit change in the primary outcome. After completing the post-intervention assessment, the participants of the control group will receive the same information booklet and hence the opportunity to be exposed to the same information as those in the intervention group.

Several strategies for enhancing adherence are integrated into the study plan. For example, frequent contacts (e.g., follow up support, newsletters and health information mails) to decrease attrition and maximize completeness of the data collection; tailoring (e.g., via profiling, readability of printed materials) to increase acceptance and logistical support (e.g., convenient schedule appointments) to limit participant burden. Additionally, an adherence monitoring mechanism will be used to ensure fidelity to the intervention. Research group meetings take place twice per month to monitor the progress of the intervention and to ensure that the protocol plan will be followed. During the first ten face-to-face and five additional randomly selected sessions during the intervention year, the second trained counsellor, using a protocol checklist, will observe the study counsellor in order to give feedback and ensure that the counselling protocol is applied as planned. Moreover, the study counsellor will complete a one-page self-assessment checklist and will make notes after each face-to-face and phone call counselling session. Notes will also be used to feed future follow-up counselling phone calls. Participants who wish to discontinue participation in the study will be asked if they want to remain for the assessments only.

Personal goals are asked using an open-ended question based on the Personal Project Analysis [61], but formulated for the purpose of studying older people’s goals [62]. Following a brief introduction on what is meant by personal goals, the participants can report all the goals they have. The total number of goals will be calculated for each participant. Moreover, the goals will be categorized into 25 goals categories and further into seven thematic goal dimensions based on their content [62].

A modified short version of the Health Care Climate Questionnaire [63] is used to assess participants’ perceptions of the degree to which they experience their social environment as autonomy-supportive versus controlling with respect to active aging. Adjustments have been made regarding the context (social support, in general provided by people) and behavior assessed (active aging). The scale consists of five items (e.g.: “I feel that other people around me have provided me with choices and options to live an active life.”) and responses are given on a Likert-type scale ranging from: “1 = strongly disagree” to “7 = strongly agree”. An individual’s score on this scale is the average of his or her responses on the five items.

The Self-Regulation Questionnaire [64] adapted to meet the needs of the intervention, is used to assess individual differences in the types of motivational regulation for being more active. The questionnaire consists of two sub-scales: autonomous motivation (4 items: e.g., “Because I enjoy being an active person”) and controlled motivation (4 items: e.g., “I would feel like a failure if I do not live an active life”). Answers are given on a Likert-type scale ranging from: 1 = “strongly disagree” to 7 = “strongly agree”. The participant’s score for each subscale is the mean score for the 4 items.

The constructs pertaining to the theory of planned behavior have been developed following the recommendations given in the manual for health services researchers [65] for the needs of the present study. Attitude towards being more active is assessed with 3 items scored on 7-point semantic differential scales ranging from 1 to 7 (“Aiming to live a more active life during the next six months means to me … pleasant - unpleasant, difficult - easy, useful - useless”). Subjective norms of active aging are assessed with one item: “I feel that the people who are important to me would want/expect me to live a more active life for the next six months”. Responses are given on a 7-point scale ranging from 1 = “strongly disagree” to 7 = “strongly agree”. Perceived behavioral control over active aging is assessed with one item: “I am confident that I can live a more active life for the next 6 months”. Responses are given on a 7-point scale ranging from 1 = “strongly disagree” to 7 = “strongly agree”. Intention for active aging is assessed using one item: “I intend to live a more active life for the next 6 months”. Responses are given on a 7-point scale ranging from: 1 = “strongly disagree” to 7 = “strongly agree”.

Age and sex are drawn from the population register. At baseline, education is assessed by number of completed years of education [66]. Perceived financial situation is assessed on a five-point scale ranging from one (very good) to five (very poor). Physical health is assessed based on self-reported physician-diagnosed diseases. A co-morbidity index similar to one previously used [67] is calculated from a checklist of diseases prompted by 10 categories of chronic diseases and an open-ended question about any other physician-diagnosed chronic conditions. Lower-extremity physical performance is assessed by the Short Physical Performance Battery (SPPB) [68‐70]. The battery comprises tests on standing balance, walking speed over a 3-m distance, and the ability to rise from a chair. Established cut-off points are used to score each task from zero to four points [69, 70], higher scores indicating better performance. Participants unable to perform a test are assigned the score zero. A sum score is calculated (range 0–12) when at least two tests are completed. Maximal isometric handgrip strength is measured on the dominant side with a hand-held adjustable dynamometer (Jamar Plus digital hand dynamometer, Patterson Medical, 6 Cedarburg, WI, USA) and expressed in kg [71]. Cognitive functioning. Cognitive functioning is assessed with the Mini-Mental State Examination (MMSE) [41]. The MMSE contains 19 items and the score ranges from 0 to 30. Changes in life situation. Major changes in life situation are assessed with five questions on changes during the last 6 months in health status, mobility or functional ability, family situation or other social relationships, hobbies, and other major changes. Answer options are “No changes”, “Yes, positive changes”, “Yes, negative changes” and “Yes, both positive and negative changes”. Those reporting changes are then asked follow-up questions to gain specific information about the changes. Finally, participants are asked what change was most significant for them and what its impact was on their life.

The following baseline measures will be used as additional information to individualize counselling: Habitation is categorized into living alone, with a spouse, with children or grandchildren, with siblings, relatives, or other people. Self-rated health is asked with the question: “How would you assess the current state of your health in general”? Answers are given on a five-point rating scale from one (very good) to five (very poor) [72]. Perceived age, i.e., how people experience their own aging on the personal level, is assessed with the question: “How old do you feel you are?” [73]. Perceived active aging is assessed by asking participants to evaluate how active their life is on a scale from 0 (not at all active) to 10 (very active) [4]. Motivation for active aging is assessed by asking participants how strongly they agree (1) or disagree (5) with the claim “I have special interests in my life” [4]. Feeling of loneliness is assessed with the question: “How often do you feel lonely?” Answers are rated on a four-point scale ranging from very rarely/never to almost always [74]. Social contacts are assessed with questions regarding the frequency of contacts with children and other relatives, close friends, and other acquaintances [67]. The response options are daily, weekly, monthly, a few times a year, rarely or not at all, and not having any children or other relatives/friends/acquaintances. Current hobbies. An open-ended question, “What are your most important hobbies?” is used to probe participants’ main hobbies. In addition, the measures of personal goals, active aging, well-being, life space mobility and depressive symptoms were used for profiling.

All interviews will end with an open-ended question asking participants whether they want to share any thoughts and feelings about the interview. Later, after completing the study, participants will be given the opportunity to share any other thoughts and feelings regarding their experiences of participation in the study.

To examine the explanatory mediators, path modelling for mediation analysis will be used. We will test the model at mid- and post- trial with active aging as the primary dependent variable, the intervention condition as the independent variable, and the psychological variables (perceived autonomy support, autonomous motivation, attitudes, subjective norms, perceived behavioral control and intentions) as multiple mediators. Potential trajectories of the outcome and explanatory variables will also be examined. The participant flow diagram during the trial is displayed in Fig. 2.